Bronchial flow control devices and methods of use

ABSTRACT

A flow control device includes a sealing component that can be positioned within a bronchial lumen. The sealing component can comprise two or more overlapping segments that are movable relative to one another such that the segments collectively form a seal that can expand and contract in size to fit within and seal bronchial lumens of various sizes.

REFERENCE TO PRIORITY DOCUMENTS

[0001] This application claims priority of the following co-pending U.S.provisional patent applications: (1) U.S. Provisional Patent ApplicationSerial No. 60/399,273, entitled “Implantable Bronchial IsolationDevices”, filed Jul. 26, 2002; and (2) U.S. Provisional PatentApplication Serial No. 60/429,902, entitled “Implantable BronchialIsolation Devices”, filed Nov. 27, 2002. Priority of the aforementionedfiling dates is hereby claimed, and the disclosures of the ProvisionalPatent Applications are hereby incorporated by reference in theirentirety.

[0002] This application is a continuation-in-part of the followingco-pending patent applications: (1) U.S. patent application Ser. No.09/797,910, entitled “Methods and Devices for Use in PerformingPulmonary Procedures”, filed Mar. 2, 2001; and (2) U.S. patentapplication Ser. No. 10/270,792, entitled “Bronchial Flow ControlDevices and Methods of Use”, filed Oct. 10, 2002. The aforementionedapplications are hereby incorporated by reference in their entireties.

BACKGROUND OF THE INVENTION

[0003] 1. Field of the Invention

[0004] This invention relates generally to methods and devices for usein performing pulmonary procedures and, more particularly, to proceduresfor treating various lung diseases.

[0005] 2. Description of the Related Art

[0006] Pulmonary diseases, such as chronic obstructive pulmonarydisease, (COPD), reduce the ability of one or both lungs to fully expelair during the exhalation phase of the breathing cycle. The term“Chronic Obstructive Pulmonary Disease” (COPD) refers to a group ofdiseases that share a major symptom, dyspnea. Such diseases areaccompanied by chronic or recurrent obstruction to air flow within thelung. Because of the increase in environmental pollutants, cigarettesmoking, and other noxious exposures, the incidence of COPD hasincreased dramatically in the last few decades and now ranks as a majorcause of activity-restricting or bed-confining disability in the UnitedStates. COPD can include such disorders as chronic bronchitis,bronchiectasis, asthma, and emphysema. While each has distinct anatomicand clinical considerations, many patients may have overlappingcharacteristics of damage at both the acinar (as seen in emphysema) andthe bronchial (as seen in bronchitis) levels.

[0007] Emphysema is a condition of the lung characterized by theabnormal permanent enlargement of the airspaces distal to the terminalbronchiole, accompanied by the destruction of their walls, and withoutobvious fibrosis. (Snider, G. L. et al: The Definition of Emphysema:Report of the National Heart Lung And Blood Institute, Division of lungDiseases Workshop. (Am Rev. Respir. Dis. 132:182, 1985). It is knownthat emphysema and other pulmonary diseases reduce the ability of one orboth lungs to fully expel air during the exhalation phase of thebreathing cycle. One of the effects of such diseases is that thediseased lung tissue is less elastic than healthy lung tissue, which isone factor that prevents full exhalation of air. During breathing, thediseased portion of the lung does not fully recoil due to the diseased(e.g., emphysematic) lung tissue being less elastic than healthy tissue.Consequently, the diseased lung tissue exerts a relatively low drivingforce, which results in the diseased lung expelling less air volume thana healthy lung. The reduced air volume exerts less force on the airway,which allows the airway to close before all air has been expelled,another factor that prevents full exhalation.

[0008] The problem is further compounded by the diseased, less elastictissue that surrounds the very narrow airways that lead to the alveoli,which are the air sacs where oxygen-carbon dioxide exchange occurs. Thediseased tissue has less tone than healthy tissue and is typicallyunable to maintain the narrow airways open until the end of theexhalation cycle. This traps air in the lungs and exacerbates thealready-inefficient breathing cycle. The trapped air causes the tissueto become hyper-expanded and no longer able to effect efficientoxygen-carbon dioxide exchange.

[0009] In addition, hyper-expanded, diseased lung tissue occupies moreof the pleural space than healthy lung tissue. In most cases, a portionof the lung is diseased while the remaining part is relatively healthyand, therefore, still able to efficiently carry out oxygen exchange. Bytaking up more of the pleural space, the hyper-expanded lung tissuereduces the amount of space available to accommodate the healthy,functioning lung tissue. As a result, the hyper-expanded lung tissuecauses inefficient breathing due to its own reduced functionality andbecause it adversely affects the functionality of adjacent healthytissue.

[0010] Lung reduction surgery is a conventional method of treatingemphysema. According to the lung reduction procedure, a diseased portionof the lung is surgically removed, which makes more of the pleural spaceavailable to accommodate the functioning, healthy portions of the lung.The lung is typically accessed through a median sternotomy or smalllateral thoracotomy. A portion of the lung, typically the periphery ofthe upper lobe, is freed from the chest wall and then resected, e.g., bya stapler lined with bovine pericardium to reinforce the lung tissueadjacent the cut line and also to prevent air or blood leakage. Thechest is then closed and tubes are inserted to remove air and fluid fromthe pleural cavity. The conventional surgical approach is relativelytraumatic and invasive, and, like most surgical procedures, is not aviable option for all patients.

[0011] Some recently proposed treatments include the use of devices thatisolate a diseased region of the lung in order to reduce the volume ofthe diseased region, such as by collapsing the diseased lung region.According to such treatments, isolation devices are implanted in airwaysfeeding the targeted region of the lung to regulate fluid flow to thediseased lung region in order to fluidly isolate the region of the lung.These implanted isolation devices can be, for example, one-way valvesthat allow flow in the exhalation direction only, occluders or plugsthat prevent flow in either direction, or two-way valves that controlflow in both directions. However, such devices are still in thedevelopment stages. For example, some valves have been found to wrinkleand create fluid leak paths when implanted in a bronchial lumen of adiameter other than that near the diameter of the valve. Thus, there ismuch need for improvement in the design, flexibility, and functionalityof such isolation devices.

[0012] In view of the foregoing, there is a need for improved methodsand devices for regulating fluid flow to a diseased lung region.

SUMMARY

[0013] Disclosed are methods and devices for regulating fluid flow toand from a region of a patient's lung, such as to achieve a desiredfluid flow dynamic to a lung region during respiration and/or to inducecollapse in one or more lung regions. In one aspect of the invention,there is disclosed a flow control device that can be implanted in abronchial passageway. The flow control device can include a sealingcomponent that can be positioned within a bronchial lumen. The sealingcomponent can comprise two or more overlapping segments that are movablerelative to one another such that the segments collectively form a sealthat can expand and contract in size to fit within and seal bronchiallumens of various sizes.

[0014] Also disclosed is a flow control device that can be implanted ina bronchial passageway. The flow control device comprises a retainerframe comprising a core, a first set of deployable arms projecting fromthe core, and a second set of deployable arms projecting from the core.The flow control device further comprises a sealing component comprisingtwo or more overlapping segments that are movable relative to oneanother such that the segments collectively form a seal that can expandand contract in size to fit within and seal bronchial lumens of varioussizes.

[0015] Also disclosed is a method of regulating fluid flow to and from aregion of an individual's lung. The method comprises placing a flowcontrol device in a bronchial passage in communication with the region,the flow control device having a first set of one or more deployablearms in a collapsed configuration; and radially expanding the first setof one or more deployable arms into engagement with a wall of thebronchial passage to anchor the flow control device therein. The flowcontrol device has a plurality of overlapping segments that are movablerelative to one another and collectively form a seal with a wall of thebronchial lumen that can expand and contract in size.

[0016] Also disclosed is a flow control device for placement in a bodylumen. The flow control device can comprise a frame comprising aplurality of struts connected to a distal hub, at least a portion ofeach strut biased outwardly from the distal hub. The flow control devicefurther comprises a membrane coupled to the struts thereby forming anumbrella shape. The frame urges the membrane into engagement with a wallof the body lumen to form a seal therewith.

[0017] Other features and advantages of the present invention should beapparent from the following description of various embodiments, whichillustrate, by way of example, the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018]FIG. 1 shows an anterior view of a pair of human lungs and abronchial tree with a flow control device implanted in a bronchialpassageway to bronchially isolate a region of the lung.

[0019]FIG. 2 shows an anterior view of a pair of human lungs and abronchial tree.

[0020]FIG. 3A shows a lateral view of the right lung.

[0021]FIG. 3B shows a lateral view of the left lung.

[0022]FIG. 4 shows an anterior view of the trachea and a portion of thebronchial tree.

[0023]FIG. 5A shows a perspective view of a first embodiment of a flowcontrol device that can be implanted in a body passageway.

[0024]FIG. 5B shows a perspective, cross-sectional view of the flowcontrol device of FIG. 5A.

[0025]FIG. 6A shows a side view of the flow control device of FIG. 5A.

[0026]FIG. 6B shows a cross-sectional, side view of the flow controldevice of FIG. 5A.

[0027]FIG. 7A shows a side, cross-sectional view of a duckbill valve ina closed state.

[0028]FIG. 7B shows a side, cross-sectional view of a duckbill valve inan open state.

[0029]FIG. 8 shows the flow control device of FIGS. 5-6 implanted in abronchial passageway.

[0030]FIG. 9 shows a perspective, cross-sectional view of anotherembodiment of the flow control device.

[0031]FIG. 10 shows a side, cross-sectional view of the flow controldevice of FIG. 9.

[0032]FIG. 11 shows a front, plan view of the flow control device ofFIG. 9.

[0033]FIG. 12 shows the flow control device of FIG. 9 implanted in abronchial passageway.

[0034]FIG. 13 shows the flow control device of FIG. 9 implanted in abronchial passageway and dilated by a dilation device comprised of atube.

[0035]FIG. 14 shows the flow control device of FIG. 9 implanted in abronchial passageway and dilated by a dilation device comprised of atube with a one-way valve.

[0036]FIG. 15 shows the flow control device of FIG. 9 implanted in abronchial passageway and dilated by a dilation device comprised of atube with a one way valve, wherein the tube is attached to a removaltether.

[0037]FIG. 16 shows the flow control device of FIG. 9 implanted in abronchial passageway and dilated by a dilation device comprised of atube, which is fluidly coupled to a catheter.

[0038]FIG. 17 shows the flow control device of FIG. 9 implanted in abronchial passageway and dilated by a dilation device comprised of acatheter.

[0039]FIG. 18 shows another embodiment of a flow control deviceimplanted in a bronchial passageway.

[0040]FIG. 19 shows a perspective view of another embodiment of a flowcontrol device.

[0041]FIG. 20 shows a side view of the flow control device of FIG. 19.

[0042]FIG. 21 shows a cross-sectional view of the flow control device ofFIG. 20 cut along the line 21-21 of FIG. 20.

[0043]FIG. 22 shows another embodiment of a flow control device.

[0044]FIG. 23 shows a cross-sectional view of the flow control device ofFIG. 22.

[0045]FIG. 24 shows a perspective view of another embodiment of a flowcontrol device.

[0046]FIG. 25 shows another embodiment of a flow control deviceimplanted in a bronchial passageway.

[0047]FIG. 26 shows another embodiment of a flow control deviceimplanted in a bronchial passageway.

[0048]FIG. 27 shows the flow control device of FIG. 26 implanted in abronchial passageway and dilated by a dilation device.

[0049]FIG. 28 shows another embodiment of a flow control deviceimplanted in a bronchial passageway.

[0050]FIG. 29 shows another embodiment of a flow control deviceimplanted in a bronchial passageway that has an internal, sealedchamber.

[0051]FIG. 30 shows another embodiment of a flow control deviceimplanted in a bronchial passageway, the flow control device having apair of internal lumens for allowing controlled, two-way fluid flow.

[0052]FIG. 31 shows another embodiment of a flow control deviceimplanted in a bronchial passageway, the flow control device having apair of flap valves for allowing controlled, two-way fluid flow.

[0053]FIG. 32 shows a delivery system for delivering a flow controldevice to a target location in a body passageway.

[0054]FIG. 33 shows a perspective view of a distal region of a deliverycatheter of the delivery system.

[0055]FIG. 34 shows a plan, side view of the distal region of thedelivery catheter.

[0056]FIG. 35A shows a cross-sectional view of a housing of the deliverycatheter, the housing containing a flow control device.

[0057]FIG. 35B shows a cross-sectional view of the housing containing aflow control device that has a distal end that protrudes from thehousing.

[0058]FIG. 36A shows the delivery catheter housing containing a flowcontrol device and implanted at a location L of a bronchial passageway.

[0059]FIG. 36B shows the delivery catheter deploying the flow controldevice at the location L of the bronchial passageway.

[0060]FIG. 37 shows the delivery catheter deploying the flow controldevice distally of the location L of the bronchial passageway.

[0061]FIG. 38 is a perspective view of a loader system for loading theflow control device onto a delivery catheter.

[0062]FIG. 39 shows a cross-sectional side view of a loader device ofthe loader system.

[0063]FIG. 40 shows a perspective view of a pusher device of the loadersystem.

[0064]FIG. 41 shows the loader system readied for loading the flowcontrol device into the housing of the delivery catheter.

[0065]FIG. 42 shows the loader system being used to compress the flowcontrol device during loading of the flow control device into thehousing of the delivery catheter.

[0066]FIG. 43 shows the loader system being used to compress the flowcontrol device during insertion of the flow control device into thehousing of the delivery catheter.

[0067]FIG. 44 shows the loader system with the flow control device fullyloaded into the housing of the delivery catheter.

[0068]FIG. 45 shows an exploded, perspective rear view of the loaderdevice of the loader system.

[0069]FIG. 46 shows a plan, rear view of the loader device of the loadersystem with a delivery door in a closed position.

[0070]FIG. 47 shows a plan, rear view of the loader device of the loadersystem with a delivery door in an open position.

[0071]FIG. 48A shows a perspective, rear view of the loader device ofthe loader system with the delivery door in an open position and thecatheter housing inserted into the loader device.

[0072]FIG. 48B shows a perspective, rear view of the loader device ofthe loader system with the delivery door in a closed position and thecatheter housing mated with the loader device.

[0073]FIG. 49 shows a perspective view of a loading tube of the loadersystem.

[0074]FIG. 50A shows the loading tube being used to initially insert theflow control device into the loader device.

[0075]FIG. 50B shows the loading tube being used to initially insert theflow control device into the loader device.

[0076]FIG. 51 shows another embodiment of a pusher device.

[0077]FIG. 52A shows the pusher device of FIG. 51 initially insertedinto the loader device.

[0078]FIG. 52B shows the pusher device of FIG. 51 fully inserted intothe loader device.

[0079]FIG. 53 shows an exploded, perspective another embodiment of theloader system.

[0080]FIG. 54 shows an exploded, perspective another embodiment of theloader system with the pusher device inserted into the loader device.

[0081]FIG. 55 shows a front, plan view of another embodiment of a loaderdevice.

[0082]FIG. 56 shows a side, plan view of the loader device of FIG. 55.

[0083]FIG. 57 shows a front, plan view of the loader device of FIG. 55in a closed state.

[0084]FIG. 58 shows a side, plan view of the loader device of FIG. 55.

[0085]FIG. 59 shows a perspective view of a flow control device having asegmented valve/seal component.

[0086]FIG. 60 is a front plan view of the valve/seal component of theflow control device depicted in FIG. 59.

[0087]FIG. 60B shows a perspective view of a flow control device havinga segmented valve/seal component and shows enlarged views of twoembodiments of foldable sections.

[0088]FIG. 61 is a side view of the flow control device depicted in FIG.59.

[0089]FIG. 62 is a side view of the flow control device depicted in FIG.59, wherein the flow control device is partially deployed.

[0090]FIG. 63 is a side view of the flow control device depicted in FIG.59, wherein the flow control device is fully retracted.

[0091]FIG. 64 is a side view of the flow control device depicted in FIG.59 placed within a bronchial lumen.

[0092]FIG. 65 is a side view of the flow control device depicted in FIG.64 fully deployed.

[0093]FIG. 66A shows a perspective view of an umbrella style flowcontrol device according to one embodiment.

[0094]FIG. 66B shows a perspective view of the flow control device ofFIG. 66 in a contracted state.

[0095]FIG. 66C shows an enlarged view of one embodiment of a retentionstrut.

[0096]FIG. 67 shows a perspective view of an umbrella style flow controldevice with a retention spring according to another embodiment.

[0097]FIG. 68 shows a perspective view of an umbrella style flow controldevice with curved struts according to another embodiment.

[0098]FIG. 69 shows a perspective view of an umbrella style flow controldevice with pleated membrane according to another embodiment.

[0099]FIG. 70 shows a perspective view of an umbrella style flow controldevice with bended struts according to another embodiment.

[0100]FIG. 71 shows a bronchoscope deployed within a bronchial tree of apatient.

[0101]FIG. 72 shows a guidewire deployed within a bronchial tree of apatient.

[0102]FIG. 73 shows a delivery catheter deployed within a bronchial treeof a patient over a guidewire.

[0103]FIG. 74 shows a perspective view of a delivery catheter having anasymmetric, distal tip.

[0104]FIG. 75 shows a perspective view of another embodiment of adelivery catheter having an asymmetric, distal tip.

[0105]FIG. 76 shows a delivery catheter having a distal curve and anasymmetric distal tip.

DETAILED DESCRIPTION

[0106] Unless defined otherwise, all technical and scientific terms usedherein have the same meaning as is commonly understood by one of skillin the art to which the invention(s) belong.

[0107] Disclosed are methods and devices for regulating fluid flow toand from a region of a patient's lung, such as to achieve a desiredfluid flow dynamic to a lung region during respiration and/or to inducecollapse in one or more lung regions. An identified region of the lung(referred to herein as the “targeted lung region”) is targeted fortreatment, such as to modify the air flow to the targeted lung region orto achieve volume reduction or collapse of the targeted lung region. Thetargeted lung region is then bronchially isolated to regulate airflowinto and/or out of the targeted lung region through one or morebronchial passageways that feed air to the targeted lung region. Asshown in FIG. 1, the bronchial isolation of the targeted lung region isaccomplished by implanting a flow control device 110 into a bronchialpassageway 115 that feeds air to a targeted lung region 120. The flowcontrol device 110 regulates airflow through the bronchial passageway115 in which the flow control device 110 is implanted, as described inmore detail below. The flow control device 110 can be implanted into thebronchial passageway using a delivery system, such as the deliverysystem catheter described herein.

[0108] Exemplary Lung Regions

[0109] Throughout this disclosure, reference is made to the term “lungregion”. As used herein, the term “lung region” refers to a defineddivision or portion of a lung. For purposes of example, lung regions aredescribed herein with reference to human lungs, wherein some exemplarylung regions include lung lobes and lung segments. Thus, the term “lungregion” as used herein can refer to a lung lobe or a lung segment. Suchlung regions conform to portions of the lungs that are known to thoseskilled in the art. However, it should be appreciated that the term lungregion does necessarily refer to a lung lobe or a lung segment, but canalso refer to some other defined division or portion of a human ornon-human lung.

[0110]FIG. 2 shows an anterior view of a pair of human lungs 210, 215and a bronchial tree 220 that provides a fluid pathway into and out ofthe lungs 210, 215 from a trachea 225, as will be known to those skilledin the art. As used herein, the term “fluid” can refer to a gas, aliquid, or a combination of gas(es) and liquid(s). For clarity ofillustration, FIG. 2 shows only a portion of the bronchial tree 220,which is described in more detail below with reference to FIG. 4.

[0111] Throughout this description, certain terms are used that refer torelative directions or locations along a path defined from an entrywayinto the patient's body (e.g., the mouth or nose) to the patient'slungs. The path generally begins at the patient's mouth or nose, travelsthrough the trachea into one or more bronchial passageways, andterminates at some point in the patient's lungs. For example, FIG. 2shows a path 202 that travels through the trachea 225 and through abronchial passageway into a location in the right lung 210. The term“proximal direction” refers to the direction along such a path 202 thatpoints toward the patient's mouth or nose and away from the patient'slungs. In other words, the proximal direction is generally the same asthe expiration direction when the patient breathes. The arrow 204 inFIG. 2 points in the proximal direction. The term “distal direction”refers to the direction along such a path 202 that points toward thepatient's lung and away from the mouth or nose. The distal direction isgenerally the same as the inhalation direction when the patientbreathes. The arrow 206 in FIG. 2 points in the distal direction.

[0112] With reference to FIG. 2, the lungs include a right lung 210 anda left lung 215. The right lung 210 includes lung regions comprised ofthree lobes, including a right upper lobe 230, a right middle lobe 235,and a right lower lobe 240. The lobes 230, 235, 240 are separated by twointerlobar fissures, including a right oblique fissure 226 and a righttransverse fissure 228. The right oblique fissure 226 separates theright lower lobe 240 from the right upper lobe 230 and from the rightmiddle lobe 135. The right transverse fissure 228 separates the rightupper lobe 230 from the right middle lobe 135.

[0113] As shown in FIG. 2, the left lung 215 includes lung regionscomprised of two lobes, including the left upper lobe 250 and the leftlower lobe 255. An interlobar fissure comprised of a left obliquefissure 245 of the left lung 215 separates the left upper lobe 250 fromthe left lower lobe 255. The lobes 230, 135, 240, 250, 255 are directlysupplied air via respective lobar bronchi, as described in detail below.

[0114]FIG. 3A is a lateral view of the right lung 210. The right lung210 is subdivided into lung regions comprised of a plurality ofbronchopulmonary segments. Each bronchopulmonary segment is directlysupplied air by a corresponding segmental tertiary bronchus, asdescribed below. The bronchopulmonary segments of the right lung 210include a right apical segment 310, a right posterior segment 320, and aright anterior segment 330, all of which are disposed in the right upperlobe 230. The right lung bronchopulmonary segments further include aright lateral segment 340 and a right medial segment 350, which aredisposed in the right middle lobe 135. The right lower lobe 240 includesbronchopulmonary segments comprised of a right superior segment 360, aright medial basal segment (which cannot be seen from the lateral viewand is not shown in FIG. 3A), a right anterior basal segment 380, aright lateral basal segment 390, and a right posterior basal segment395.

[0115]FIG. 3B shows a lateral view of the left lung 215, which issubdivided into lung regions comprised of a plurality ofbronchopulmonary segments. The bronchopulmonary segments include a leftapical segment 410, a left posterior segment 420, a left anteriorsegment 430, a left superior segment 440, and a left inferior segment450, which are disposed in the left lung upper lobe 250. The lower lobe255 of the left lung 215 includes bronchopulmonary segments comprised ofa left superior segment 460, a left medial basal segment (which cannotbe seen from the lateral view and is not shown in FIG. 3B), a leftanterior basal segment 480, a left lateral basal segment 490, and a leftposterior basal segment 495.

[0116]FIG. 4 shows an anterior view of the trachea 225 and a portion ofthe bronchial tree 220, which includes a network of bronchialpassageways, as described below. The trachea 225 divides at a distal endinto two bronchial passageways comprised of primary bronchi, including aright primary bronchus 510 that provides direct air flow to the rightlung 210, and a left primary bronchus 515 that provides direct air flowto the left lung 215. Each primary bronchus 510, 515 divides into a nextgeneration of bronchial passageways comprised of a plurality of lobarbronchi. The right primary bronchus 510 divides into a right upper lobarbronchus 517, a right middle lobar bronchus 520, and a right lower lobarbronchus 522. The left primary bronchus 515 divides into a left upperlobar bronchus 525 and a left lower lobar bronchus 530. Each lobarbronchus, 517, 520, 522, 525, 530 directly feeds fluid to a respectivelung lobe, as indicated by the respective names of the lobar bronchi.The lobar bronchi each divide into yet another generation of bronchialpassageways comprised of segmental bronchi, which provide air flow tothe bronchopulmonary segments discussed above.

[0117] As is known to those skilled in the art, a bronchial passagewaydefines an internal lumen through which fluid can flow to and from alung. The diameter of the internal lumen for a specific bronchialpassageway can vary based on the bronchial passageway's location in thebronchial tree (such as whether the bronchial passageway is a lobarbronchus or a segmental bronchus) and can also vary from patient topatient. However, the internal diameter of a bronchial passageway isgenerally in the range of 3 millimeters (mm) to 10 mm, although theinternal diameter of a bronchial passageway can be outside of thisrange. For example, a bronchial passageway can have an internal diameterof well below 1 mm at locations deep within the lung.

[0118] Stented Flow Control Devices

[0119] As discussed, the flow control device 110 can be implanted in abronchial passageway to regulate the flow of fluid through the bronchialpassageway. When implanted in a bronchial passageway, the flow controldevice 110 anchors within the bronchial passageway in a sealing fashionsuch that fluid in the bronchial passageway must pass through the flowcontrol device in order to travel past the location where the flowcontrol device is located. The flow control device 110 has fluid flowregulation characteristics that can be varied based upon the design ofthe flow control device. For example, the flow control device 110 can beconfigured to either permit fluid flow in two directions (i.e., proximaland distal directions), permit fluid flow in only one direction(proximal or distal direction), completely restrict fluid flow in anydirection through the flow control device, or any combination of theabove. The flow control device can be configured such that when fluidflow is permitted, it is only permitted above a certain pressure,referred to as the cracking pressure. As described in detail below, theflow control device 110 can also be configured such that a dilationdevice can be manually inserted into the flow control device 110 to varythe flow properties of the flow control device 110.

[0120] FIGS. 5-6 show a first embodiment of a flow control device 110.FIG. 5A shows a perspective view of the device 110, FIG. 5B shows aperspective, cross-sectional view of the device 110, FIG. 6A shows aplan, side view of the device 110, and FIG. 6B shows a cross-sectional,plan, side view of the device 110. The flow control device 110 extendsgenerally along a central axis 605 (shown in FIGS. 5B and 6B) and has aproximal end 602 and a distal end 604. The flow control device 110includes a main body that defines an interior lumen 610 through whichfluid can flow along a flow path that generally conforms to the centralaxis 605.

[0121] The flow of fluid through the interior lumen 610 is controlled bya valve member 612 that is disposed at a location along the interiorlumen such that fluid must flow through the valve member 612 in order toflow through the interior lumen 610, as described more fully below. Itshould be appreciated that the valve member 612 could be positioned atvarious locations along the interior lumen 610. The valve member 612 canbe made of a biocompatible material, such as a biocompatible polymer,such as silicone. The size of the valve member 612 can vary based on avariety of factors, such as the desired cracking pressure of the valvemember 612.

[0122] The flow control device 110 has a general outer shape and contourthat permits the flow control device 110 to fit entirely within a bodypassageway, such as within a bronchial passageway. Thus, as best shownin FIGS. 5A and 5B, the flow control device 110 has a generally circularshape (when viewed longitudinally along the axis 605) that willfacilitate insertion of the flow control device into a bronchialpassageway. A circular shape generally provides a good fit with abronchial passageway, although it should be appreciated that the flowcontrol device 110 can have other cross-sectional shapes that enable thedevice 110 to be inserted into a bronchial passageway.

[0123] With reference to FIGS. 5-6, the flow control device 110 includesan outer seal member 615 that provides a seal with the internal walls ofa body passageway when the flow control device is implanted into thebody passageway. The seal member 615 is manufactured of a deformablematerial, such as silicone or a deformable elastomer. The flow controldevice 110 also includes an anchor member 618 that functions to anchorthe flow control device 110 within a body passageway. The configurationsof the seal member 615 and the anchor member 618 can vary, as describedbelow.

[0124] As shown in FIGS. 5-6, the seal member 615 is generally locatedon an outer periphery of the flow control device 110. In the embodimentshown in FIGS. 5-6, the seal member includes a series ofradially-extending, circular flanges 620 that surround the outercircumference of the flow control device 110. The flanges 620 can bemanufactured of silicone or other deformable elastomer. As best shown inFIG. 6B, the radial length of each flange 620 varies moving along thelongitudinal length (as defined by the longitudinal axis 605 in FIG. 6B)of the flow control device 110. It should be appreciated that the radiallength could be equal for all of the flanges 620 or that the radiallength of each flange could vary in some other manner. For example, theflanges 620 can alternate between larger and shorter radial lengthsmoving along the longitudinal length of the flow control device, or theflanges can vary in a random fashion. In addition, the flanges 620 couldbe oriented at a variety of angles relative to the longitudinal axis 605of the flow control device. In another embodiment, the radial length ofa single flange could vary so that the circumference of the flange issinusoidal about the center of the flange.

[0125] In the embodiment shown in FIGS. 5-6, the seal member 615includes a cuff 622. As can be seen in the cross-sectional views ofFIGS. 5B and 6B, the cuff 622 comprises a region of the seal member 615that overlaps on itself so as to form a cavity 623 within the cuff 622.As described below, the cavity 623 can be used to retain the anchormember 618 to the seal member 615 of the flow control device 110. Thecuff 622 can function in combination with the flanges 620 to seal theflow control device to the internal walls of a bronchial lumen when theflow control device is implanted in a bronchial lumen, as describedbelow. The cuff 622 can be formed in a variety of manners, such as byfolding a portion of the seal member 615 over itself, or by molding theseal member 615 to form the cuff 622.

[0126] As mentioned, the anchor member 618 functions to anchor the flowcontrol device 110 in place when the flow control device is implantedwithin a body passageway, such as within a bronchial passageway. Theanchor member 618 has a structure that can contract and expand in size(in a radial direction and/or in a longitudinal direction) so that theanchor member can expand to grip the interior walls of a body passagewayin which the flow control device is positioned. In one embodiment, asshown in FIGS. 5 and 6, the anchor member 618 comprises an annular frame625 that surrounds the flow control device 110. The frame 625 is formedby a plurality of struts that define an interior envelope sized tosurround the interior lumen 610.

[0127] As shown in FIGS. 5-6, the struts of the frame 625 form curved,proximal ends 629 that can be slightly flared outward with respect tothe longitudinal axis 605. When the flow control device 110 is placed ina bronchial lumen, the curved, proximal ends 629 can anchor into thebronchial walls and prevent migration of the flow control device in aproximal direction. The frame 625 can also have flared, distal prongs627 that can anchor into the bronchial walls and to prevent the device110 from migrating in a distal direction when the flow control device110 is placed in a bronchial lumen. The frame 625 can be formed from asuper-elastic material, such as Nickel Titanium (also known as Nitinol),such as by cutting the frame out of a tube of Nitinol or by forming theframe out of Nitinol wire. The super-elastic properties of Nitinol canresult in the frame exerting a radial force against the interior wallsof a bronchial passageway sufficient to anchor the flow control device110 in place.

[0128] The struts are arranged so that the frame 625 can expand andcontract in a manner that is entirely or substantially independent ofthe rest of the flow control device 110, including the valve member 612,as described more fully below. In the embodiment shown in FIGS. 5-6, theframe 625 is attached to the flow control device 110 inside the cavity623 of the cuff 622. That is, at least a portion of the frame 625 ispositioned inside the cavity 623. The frame 625 is not necessarilyfixedly attached to the cavity. Rather, a portion of the frame 625 ispositioned within the cavity 623 so that the frame 625 can freely movewithin the cavity, but cannot be released from the cavity. An attachmentmeans can be used to attach the opposing pieces of the cuff 622 to oneanother so that the frame 625 cannot fall out of the cavity 623. In oneembodiment, the attachment means comprises an adhesive, such as siliconeadhesive, that is placed inside the cavity 623 and that adheres theopposing pieces of the cuff 622 to one another. In an alternativeembodiment, described below, rivets are used to attach the opposingpieces of the cuff. It should be appreciated, however, that differentattachment means could be used to secure the frame 625 to the sealmember 615. Furthermore, it should be appreciated that the frame 625 isnot necessarily bonded to the seal member 615. In yet anotherembodiment, the frame 625 can be integrally formed with the valveprotector member 637, described below.

[0129] As mentioned, the valve member 612 regulates the flow of fluidthrough the interior lumen 610 of the flow control device 110. In thisregard, the valve member 612 can be configured to permit fluid to flowin only one-direction through the interior lumen 610, to permitregulated flow in two-directions through the interior lumen 610, or toprevent fluid flow in either direction. The valve member 612 ispositioned at a location along the interior lumen 610 so that fluid musttravel through the valve member 612 in order to flow through theinterior lumen 610.

[0130] The valve member 612 can be any type of fluid valve, andpreferably is a valve that enables the cracking pressures describedherein. The valve member 612 can have a smaller diameter than the frame625 so that compression or deformation of the frame 625 in both a radialand axial direction will have little or no impact on the structure ofthe valve member 612. In the embodiment shown in FIGS. 5-6, the valvemember 612 comprises a duckbill valve that includes two flaps 631 (shownin FIGS. 5B and 6B) that are oriented at an angle with respect to oneanother and that can open and close with respect to one another so as toform an opening at a lip 801 (FIG. 6B) where the flaps 631 touch oneanother. The duckbill valve operates according to a conventionalduckbill valve in that it allows fluid flow in a first direction andprevents fluid flow in a second direction that is opposed to the firstdirection. For example, FIG. 7A shows a schematic side-view of theduckbill valve in a closed state, wherein the flaps 631 touch oneanother at the lip 801. In the closed state, the duckbill valve preventsfluid flow in a first direction, which is represented by the arrow A inFIG. 7A. However, when exposed to fluid flow in a second direction(represented by arrow B in FIG. 7B) that is opposed to the firstdirection, the flaps 631 separate from one another to form an openingbetween the flaps 631 that permits flow in the second direction, asshown in FIG. 7B.

[0131] With reference again to FIG. 6B, the valve member 612 isconcentrically contained within the seal member 615. In addition, atleast a portion of the valve member 612 is optionally surrounded by arigid or semi-rigid valve protector member 637 (shown in FIGS. 5B and6B), which is a tubular member or annular wall that is contained insidethe seal member 622. In another embodiment, the valve protector cancomprise a coil of wire or a ring of wire that provides some level ofstructural support to the flow control device. The valve protector 637can be concentrically located within the seal member 615. Alternately,the valve member 612 can be completely molded within the seal member 615such that the material of the seal member 615 completely surrounds thevalve protector.

[0132] The valve protector member 637 is optional, although whenpresent, the valve protector member 637 protects the valve member 612from damage and can maintain the shape of the flow control device 110against compression and constriction to a certain extent. The valveprotection member 637 can also support and stiffen the flanges 620. Thevalve protector member 637 can be manufactured of a rigid, biocompatiblematerial, such as, for example, nickel titanium, steel, plastic resin,and the like. In one embodiment, the valve protector member 637 has twoor more windows 639 comprising holes that extend through the valveprotector member, as shown in FIG. 6B. The windows 639 can provide alocation where a removal device, such as graspers or forceps, can beinserted in order to facilitate removal of the flow control device 110from a bronchial passageway.

[0133] The valve protector member 637 can be formed out of a solid tubeof a super-elastic material such as Nitinol. In one embodiment, thevalve protector member 637 is compressible to a smaller diameter forloading into a delivery catheter. The compressibility can be achieved byforming the valve protector member 637 out of a series of struts or byincluding some open spaces in the valve protector member 637. Thesuper-elastic characteristics of Nitinol would allow the valve protectormember 637 to be compressed during deployment, yet still allow it toexpand once deployed.

[0134] The seal 615 and/or the frame 625 can contract or expand in size,particularly in a radial direction. The default state is an expandedsize, such that the flow control device 110 will have a maximum diameter(which is defined by either the seal 615 or the frame 625) when the flowcontrol device 110 is in the default state. The flow control device 110can be radially contracted in size during insertion into a bronchialpassageway, so that once the flow control device 110 is inserted intothe passageway, it expands within the passageway.

[0135] In one embodiment, the valve member 612 and frame 625 areindependently enlargeable and contractible. Alternately, the frame 625can be enlargeable and contractible, while the valve member 612 is notenlargeable and contractible. The independent collapsibility of thevalve member 612 and frame 625 facilitate deployment and operation ofthe flow control device 110. The flow control device 110 can becompressed from a default, enlarged state and implanted in a desiredlocation within a bronchial passageway. Once implanted, the flow controldevice 110 automatically re-expands to anchor within the location of thebronchial passageway. The independent compression of the frame and valvemember reduces the likelihood of damage to the flow control device 110during deployment. Furthermore, the valve can be substantially immune tothe effects of compression of the frame 625. In one embodiment, thediameter of the frame 625 may collapse as much as 80% without affectingthe valve member 612 so that the valve member 612 will still operatenormally. The flow control device 110 does not have to be preciselysized for the lumen it is to be placed within. This affords medicalproviders with the option of buying smaller volumes of the flow controldevice 110 and being able to provide the same level and scope ofcoverage for all patients.

[0136] The dimensions of the flow control device 110 can vary based uponthe bronchial passageway in which the flow control device 110 isconfigured to be implanted. As mentioned, the valve member does not haveto be precisely sized for the bronchial passageway it is to be placedwithin. Generally, the diameter D (shown in FIG. 6A) of the flow controldevice 110 in the uncompressed state is larger than the inner diameterof the bronchial passageway in which the flow control device 110 will beplaced. This will permit the flow control device 110 to be compressedprior to insertion in the bronchial passageway and then expand uponinsertion in the bronchial passageway, which will provide for a securefit between the flow control device 110 and the bronchial passageway.

[0137]FIG. 8 shows the flow control device 110 of FIGS. 5-6 implantedwithin a bronchial passageway 910 having interior walls 915 that definea lumen of the bronchial passageway 910. As is known to those skilled inthe art, fluids (such as air) can travel to a region of the lung throughthe lumen of the bronchial passageway 910.

[0138] As shown in FIG. 8, the flow control device 110 is implanted suchthat one or more of the flanges 620 contact the interior walls 915 toprovide a seal that prevents fluid from flowing between the interiorwalls 915 and the flanges 620. The cuff 622 can also provide a seal withthe bronchial passageway. At least a portion of the outermost surface ofthe cuff 622 sealingly engages the surface of the interior walls 915.Thus, the flanges 620 and the cuff 622 both provide a seal between theinterior walls 915 of the bronchial passageway 910 and the flow controldevice 110.

[0139] Thus, fluid must flow through the interior lumen 610 of the flowcontrol device 110 in order to flow from a proximal side 1301 of theflow control device 110 to a distal side 1302 or vice-versa. That is,the flanges 620 and cuff 620 form a seal with the interior wall 915 toprevent fluid from flowing around the periphery of the flow controldevice 110, thereby forcing fluid flow to occur through the internallumen of the flow control device 110, and specifically through the valvemember 612.

[0140] As shown in FIG. 8, the valve member 612 is oriented such that itwill permit regulated fluid flow in the proximal direction 204, butprevent fluid in a distal direction 206 through the flow control device110. The valve member 612 will only permit fluid flow therethrough whenthe fluid reaches a predetermined cracking pressure, as described below.Other types of valve members, or additional valve members, could be usedto permit fluid flow in both directions or to prevent fluid flow ineither direction.

[0141] As shown in FIG. 8, the frame 625 grips the interior wall 915 andpresses against the wall 915 with a pressure sufficient to retain theflow control device 110 in a fixed position relative to the bronchialpassageway. The prongs 627 are positioned such that they lodge againstthe interior walls 915 and prevent the flow control device 110 frommigrating in a distal direction 206. The curved, distal ends 629 of theframe 625 can lodge against the interior walls 915 and prevent migrationof the flow control device 110 in a proximal direction 204.

[0142] When the flow control device 110 is properly implanted, the frame625 does not necessarily return to its original expanded state afterbeing implanted, but may be deformed and inserted such that one side iscollapsed, or deformed relative to its pre-insertion shape. The frame625 preferably has sufficient outward radial force to maintain the flowcontrol device's position in the bronchial passageway. Due to thesubstantially independent deformation of the frame 625, even if theframe 625 is implanted in a deformed state, the seal member 615 canstill maintain a true and complete contact with the walls of thebronchial passageway.

[0143] The frame 625 expands to grip the bronchial wall when the flowcontrol device 110 is implanted in the bronchial passageway. Thus, theframe 625 can be in at least two states, including an insertion(compressed) state and an anchoring (expanded or uncompressed) state. Inthe insertion state, the frame 625 has a smaller diameter than in theanchoring state. Various mechanisms can be employed to achieve the twostates. In one embodiment, the frame 625 is manufactured of a malleablematerial. The frame 625 can be manually expanded to the anchoring state,such as by inserting an inflatable balloon inside the frame once theflow control device 110 is implanted in the bronchial passageway, andthen inflating the balloon to expand the frame beyond the material'syield point into an interfering engagement with the wall of thebronchial passageway.

[0144] Another mechanism that can be employed to achieve the two-stateframe 625 size is spring resilience. The insertion state can be achievedthrough a preconstraint of the frame 625 within the elastic range of theframe material. Once positioned in the bronchial passageway, the frame625 can be released to expand into an anchoring state. Constrainingtubes or pull wires may achieve the initial insertion state.

[0145] Another mechanism that can be used to achieve both the insertionand the anchor states of the frame 625 is the heat recovery of materialsavailable with alloys, such as certain nickel titanium alloys, includingNitinol. The transition temperature of the frame 625 could be below bodytemperature. Under such a circumstance, a cool frame 625 can bepositioned and allowed to attain ambient temperature. The unrecoveredstate of the frame 625 would be in an insertion position with the frame625 having a smaller diameter. Upon recovery of the frame material, theframe 625 would expand, such as when the frame achieves a temperaturewithin the bronchial passageway. Another use of this material may bethrough a heating of the device above body temperature with a recoverytemperature zone above that of normal body temperature but below atemperature which may cause burning. The device might be heatedelectrically or through the modulation of a field.

[0146] In one embodiment, the outer diameter of the seal member 615 ofthe flow control device 110 (in an uncompressed state) is in the rangeof approximately 0.20 inches to 0.42 inches at the flanges 620 or at thecuff 622. In one embodiment, the frame 625 has an outer diameter (in anuncompressed state) in the range of approximately 0.24 to 0.48 inches.In one embodiment, the flow control device 110 has an overall lengthfrom the proximal end 602 to the distal end 604 of approximately 0.35inches to 0.52 inches. It should be appreciated that the aforementioneddimensions are merely exemplary and that the dimensions of the flowcontrol device 110 can vary based upon the bronchial passageway in whichit will be implanted.

[0147] FIGS. 9-11 show another embodiment of the flow control device110. FIG. 9 shows a perspective, cross-sectional view, FIG. 10 shows aside, cross-sectional view, and FIG. 11 shows a front, plan view of theother embodiment of the flow control device 110. Unless noted otherwise,like reference numerals and like names refer to like parts as theprevious embodiment. This embodiment of the flow control device has ananchor member 618 comprising a frame 625 that is disposed in a spacedrelationship from the rest of the flow control device 110. That is, theframe 625 is distally-spaced from the seal member 615 and the internallumen 610. As in the previous embodiment, the flow control device 110extends generally along a central axis 605 (shown in FIGS. 9 and 10) andhas a main body that defines an interior lumen 610 through which fluidcan flow along a flow path that generally conforms to the central axis605. The interior lumen 610 is surrounded by an annular wall 608. Theflow of fluid through the interior lumen is controlled by a valve member612. FIG. 9 shows the valve member 612 located at an end of the interiorlumen 610, although it should be appreciated that the valve member 612could be positioned at various locations along the interior lumen 610.

[0148] As best shown in FIG. 11, the flow control device 110 has agenerally circular shape (when viewed longitudinally) that willfacilitate insertion of the flow control device into a bronchialpassageway, although it should be appreciated that the flow controldevice 110 can have other cross-sectional shapes that enable the deviceto be inserted into a bronchial passageway.

[0149] As best shown in FIGS. 9 and 10, the seal member 615 is locatedon an outer periphery of the flow control device 110. In the embodimentshown in FIGS. 9-11, the seal member includes a series ofradially-extending, circular flanges 620 that surround the entire outercircumference of the flow control device 110.

[0150] With reference to FIGS. 9 and 10, the anchor member 618 is shownlocated on a distal end of the flow control device 110, although theanchor member 618 can be located at various locations along the flowcontrol device 110. In the embodiment shown in FIGS. 9-11, the frame 625is attached to the flow control device 110 by one or more attachmentstruts 626 although the frame 625 could also be attached in othermanners.

[0151] In the embodiment shown in FIGS. 9-11, the valve member 612comprises a septum 630 located at a proximal end of the interior lumen610. In a default state, the septum 630 occludes fluid from flowingthrough the interior lumen 610 so that the flow control device 110 shownin FIGS. 9-11 can function as an occluder that prevents flow in eitherdirection. However, the septum 630 can be pierced by a dilator device(described below) via a slit 635 in the septum 630, in order to permitfluid to flow through the interior lumen 610. The septum 630 is madefrom a deformable elastic material.

[0152] The dilator device could comprise a wide variety of devices thatfunction to dilate the slit 635 in the septum 630 and thereby provide apassageway across the flow device 110 through which fluid can flow inone or two directions, depending on the design of the dilator device.The dilator devices could comprise, for example:

[0153] (1) A suction catheter for aspirating air or fluid distal to theflow control device.

[0154] (2) A long, thin suction catheter that could be snaked into verydistal portions of the isolated lung region for aspirating fluid or airin the distal portions of the isolated lung regions.

[0155] (3) A short tube to allow free fluid communication between theoccluded region of a bronchial passageway distal of an implanted flowcontrol device and the region of the bronchial passageway proximal ofthe implanted flow control device.

[0156] (4) A tube or other short structure with a one-way valve mountedinside to allow fluid to be expelled from the isolated distal lungregion (either during normal exhalation or during a procedure thatforces fluid from the isolated, distal lung region) and to prevent fluidfrom entering the isolated lung region.

[0157] (5) A catheter with a one-way valve mounted at the tip to allowfluid to be expelled from the isolated, distal lung region (eitherduring normal exhalation or during a procedure that forces fluid fromthe distal lung segment) and to prevent fluid from entering the lungsegment.

[0158] (6) A catheter for instilling a therapeutic agent, such asantibiotics or other medication, into the region of the bronchialpassageway or lung distal to the flow control device that has beenimplanted in the bronchial passageway.

[0159] (7) A catheter for passing brachytherapy sources into thebronchial passageway distal to the implanted flow control device fortherapeutic reasons, such as to stop mucus production, kill a pneumoniainfection, etc. The brachytherapy source can be configured to emiteither Gamma or Beta radiation.

[0160] (8) A catheter with a semi-permeable distal aspect thatcirculates a nitrogen-solvent fluid, which absorbs through osmosisnitrogen trapped in the lung region distal to the flow control device.

[0161] Thus, the dilator devices described above generally fall into twocategories, including catheter-type dilation devices and dilationdevices comprised of short, tube-like structures. However, it should beappreciated that flow control device 110 can be used with variousdilation devices that are not limited to those mentioned above.

[0162] The deployment of the flow control device 110 and use of adilator device therewith is described in more detail with reference toFIGS. 12 and 13. The use of a dilator device is described in the contextof being used with one of the flow control device 110 described herein,although it should be appreciated that the dilator device can be usedwith other types of flow control devices and is not limited to beingused with those described herein. FIGS. 12 and 13 show the flow controldevice 110 of FIGS. 9-11 implanted within a bronchial passageway 910having interior walls 915 that define a lumen of the bronchialpassageway 910.

[0163] As shown in FIG. 12, the flow control device 110 is implantedsuch that one or more of the flanges 620 contact the interior walls 915to provide a seal that prevents fluid from flowing between the interiorwalls 915 and the flanges 620. Thus, fluid must flow through theinterior lumen 610 of the flow control device 110 in order to flow froma proximal side 1301 of the flow control device 110 to a distal side1302 or vice-versa.

[0164] It should be appreciated that the relative locations of theflanges 620 and the frame 625 along the longitudinal axis of the flowcontrol device can be changed. For example, the flanges 620 could belocated on the distal side of the flow control device 110 rather than onthe proximal side, and the frame 625 can be located on the proximal siderather than the distal side. The flow control device 110 could also bepositioned in a reverse orientation in the bronchial passageway thanthat shown in FIG. 12. In such a case, the orientation of the valvemember 612 could be arranged to permit flow in a desired direction, suchas in a proximal direction 204 (to allow air flow out of a lung region),a distal direction 206 (to allow air flow into a lung region), or inboth directions. The orientation of the flanges 620 can also be changedbased upon how the flow control device 110 is to be implanted in thebronchial passageway.

[0165] As discussed, the frame 625 grips the interior wall 915 andpresses against the wall 915 with a pressure sufficient to retain theflow control device 110 in a fixed position. When in the state shown inFIG. 12, the flow control device 110 obstructs the bronchial passageway910 to prevent fluid from flowing in either direction through thebronchial passageway 910. In this regard, the septum 630 can besufficiently rigid so that the slit 635 does not open when subjected toexpiration and inhalation pressures. As described further below, otherembodiments of the flow control device 110 can be used to provideregulated fluid flow through the bronchial passageway 910 in a distaldirection, a proximal direction, or in both the distal and proximaldirections.

[0166] With reference now to FIG. 13, the septum 630 can be mechanicallypierced through the slit 635, such as by using a dilator devicecomprised of a tube 1010 that dilates the slit 635. Alternately, theseptum 630 can have no slit 635 and the tube 1010 can be used to piercethrough the septum 630. In either case, the septum 630 preferably sealsaround the outer surface of the tube 1010 in order to prevent fluid flowin the space between the septum 630 and the tube 1010. The tube 1010 ishollow and has an internal lumen such that the tube 1010 provides anunobstructed fluid flow passageway between a region of the bronchialpassageway 910 distal of the flow control device 110 and a region of thebronchial passageway proximal of the flow control device 110.

[0167] Various dilator devices can be inserted through the flow controldevice 110 to provide various flow characteristics to the flow controldevice, as well as to provide access to the region of the bronchialpassageway located distal of the flow control device 110. In any of theembodiments of the dilation devices and flow control devices describedherein, it should be appreciated that the dilation device can bepre-loaded into the flow control device 110 prior to deploying the flowcontrol device 110 to the bronchial passageway. Alternately, the flowcontrol device 110 can be implanted into the bronchial passagewaywithout the dilation device and the dilation device inserted into theflow control device 110 after implant of the flow control device 110.

[0168]FIG. 14 shows another embodiment wherein the dilator devicecomprises a tube section 1110 that includes a one-way valve 1120 mountedthereon. The one-way valve 1120 can be any type of valve that permitsfluid flow in a first direction but prevents fluid flow in a seconddirection opposite to the first direction. For example, as shown in FIG.14, the one-way valve 1120 can comprise a duckbill valve of the typeknown to those skilled in the art. The one-way valve 1120 can bepositioned such that it allows fluid flow in an exhalation direction(i.e., proximal direction) 204 but prohibits fluid flow in an inhalationdirection (i.e., distal direction) 206.

[0169]FIG. 15 shows the flow control device 110 with the septum 630dilated by a tube section 1110 that includes a one-way valve 1120mounted thereon. The tube section 1110 has an attachment structure, suchas a flange 1210. A remote actuator, such as a tether 1215, is attachedat a proximal end to the attachment structure 1210 of the tube section1110. The tether 1215 can be formed of a variety of bio-compatiblematerials, such as any well-known suture material. The tether 1215extends in a proximal direction through the bronchial passageway 910 andthrough the trachea (shown in FIG. 2) so that a proximal end of thetether 1215 protrudes through the mouth or nose of the patient. Thetether can be pulled outwardly, which will also cause the attached tubestructure 1110 to be pulled outwardly from the septum 630 by virtue ofthe tether's attachment to the tube attachment structure 1210. Theabsence of the tube structure 110 would then cause the septum 630 tore-seal so that the flow control device 110 again occludes fluid flowthrough the bronchial lumen 910.

[0170]FIG. 16 shows the flow control device 110 implanted in thebronchial lumen 910, with the septum 630 dilated by a tube section 1110that includes a one-way valve 1120 mounted thereon. The one-way valve1120 fluidly communicates with the internal lumen of a catheter 1310 ata distal end of the catheter 1310. The catheter 1310 extends in aproximal direction through the bronchial passageway 910 and through thetrachea (shown in FIG. 2) so that a proximal end of the catheter 1310protrudes through the mouth or nose of the patient. The catheter 1310thereby provides an airflow passageway for fluid flowing through theone-way valve 1120. Thus, the catheter 1310 in combination with theone-way valve 1120 and the flow control device 110 provide a regulatedfluid access to the bronchial passageway 910 at a location distal of theflow control device 110. The catheter 1310 can thus be used to aspiratefluid from a location distal of the flow control device 110 by applyinga suction to the proximal end of the catheter 1310, which suction istransferred to the distal region of the bronchial passageway through theinternal lumen of the catheter 1310, the tube section 1110, and the flowcontrol device 110. The catheter optionally has one or more vent holes1320 at a location proximal of the one-way valve 1120. The vent holes1320 permit fluid to flow from the internal lumen of the catheter 1310into the bronchial passageway proximal of the flow control device 110.

[0171]FIG. 17 shows the flow control device 110 mounted within thebronchial passageway 910, with the slit of the septum 630 dilated by acatheter 1310. A distal end of the catheter 1310 is located distally ofthe septum 630. The catheter 1310 extends in a proximal directionthrough the bronchial passageway 910 and through the trachea (shown inFIG. 2) so that a proximal end of the catheter 1310 protrudes throughthe mouth or nose of the patient. The catheter 1310 provides an airflowpassageway across the flow control device 110. Thus, the catheter 1310provides unobstructed fluid access to the bronchial passageway 910 at alocation distal of the flow control device 110. The catheter 1310 canthus be used to aspirate fluid from a location distal of the flowcontrol device 110 by applying a suction to the proximal end of thecatheter 1310, which suction is transferred to the distal region of thebronchial passageway through the internal lumen of the catheter 1310.The catheter 1310 also enables the instillation of therapeutic agentsinto the distal side of the flow control device, the passing ofbrachytherapy sources to the distal side of the flow control device,etc, all via the internal lumen of the catheter 1310.

[0172]FIG. 18 shows an alternate embodiment of the flow control device110 mounted in a bronchial passageway. This embodiment of the flowcontrol device 110 is identical to that described above with referenceto FIGS. 9-11, with the exception of the configuration of the septum 630and the slit 635. A distal face of the septum has a taper 1510 locatedat the slit 635. The taper 1510 functions to reduce the crackingpressure required to open slit 635 so that the cracking pressure of theseptum 630 will be lower for flow moving from the distal side 1302toward the proximal side 1301 of the flow control device 110, and higherfor flow from the proximal side 1510 to the distal side 1520. Thecracking pressure can be made the same in both directions by eliminatingthe taper 1510. The cracking pressure can be varied by changing thedurometer of the elastomer, by changing the diameter of the valve, bychanging the length of the slit 635, by changing the angle, depth orshape of the taper feature 1510, or by changing the thickness of thevalve feature.

[0173] FIGS. 19-21 show another embodiment of the flow control device110, which permits fluid flow in a first direction but prevents fluidflow in a second direction opposite the first direction. As in theprevious embodiments, the flow control device 110 includes a seal member615, a valve member 612, and an anchor member 618, as well as aninterior lumen 610 formed by an annular wall 608 (shown in FIG. 21). Theannular wall 608 can be made from Nitinol, injection molded plastic suchas polyetheretherketone (PEEK), or other rigid biocompatible materials.As in the previous embodiments, the anchor member 618 comprises a frame625 that is formed by a plurality of struts that define an interiorenvelope. The frame 625 can contract and expand in a radial andlongitudinal direction (relative to the longitudinal axis 1805 shown inFIG. 21). The struts of the frame 625 are arranged so that one or moreof the struts form prongs 1605 having edges that can wedge against theinterior wall of a body passageway to secure an implanted flow controldevice against movement within the body passageway. The anchor member618 can be manufactured of a shape-memory material, such as nickeltitanium or Nitinol.

[0174] In the embodiment of the flow control device 110 shown in FIGS.19-21, the valve member 612 comprises a one-way flap valve that permitsfluid flow in a first flow direction. The flap valve includes a flap1610, which can move between a closed position and an open position (theflap 1610 is shown in an open position in FIGS. 19-21). In the closedposition, the flap 1610 sits within a seat to block fluid flow throughthe interior lumen 610. In the open position, the flap provides anopening into the interior lumen 610 so that fluid can flow through theinterior lumen in the first flow direction.

[0175] As in the previous embodiment, the seal member 615 includes oneor more flanges 620 that can seal against the interior wall of a bodypassageway in which the flow control device 110 is implanted. As shownin FIGS. 21, the flanges 625 of the seal member 615 surround the annularwall 608 that forms the interior lumen 610. The flap 1610 and the sealmember 615 can be manufactured of an elastomeric material such assilicone, thermoplastic elastomer, urethane, etc. The flap 1610 can alsobe a rigid member that seals against an elastomer surface of the device110, or it could be rigid and lined with an elastomer material. If arigid flap is used, then hinges can be used to attach the flap to thedevice 110.

[0176] At a distal end 1607 of the flow control device 110, the sealmember 615 folds over itself to form an annular cuff 1625. At least aportion of the frame 625 is positioned within the cuff and retainedtherein using retaining members, such as rivets 1630 that extend throughholes in the cuff 1625. The rivets 1630 can be manufactured of abio-compatible material, such as silicone adhesive. The rivets 1630secure the cuff 1625 to the frame 625 so as to allow the frame 625 toexpand and contract, but to still firmly capture the frame 625 to thecuff 1625. As best shown in the section view of FIG. 21, the rivets 1630extend between opposed sides of the cuff 1625 to capture but not totallyrestrain the frame 625 against expansion or contraction. It should beappreciated that other attachment means can be used to attach the frame625 to the cuff 1625. For example, adhesive can be used as in thepreviously-described embodiments.

[0177] Multiple rivets 1630 may be used in any variety of patternsaround the circumference of the cuff 1625. While the rivets 1630 may beshort in length such that there is little play between the folded overregion of the cuff 1625 and the portion of the cuff 1625 located withinthe frame envelope, the rivets 1630 may be lengthened so that there issubstantial play between the folded-over portion of the cuff 1625 andthe interior region of the cuff 1625. In this manner, the frame 625 canbe crumpled or deformed during deployment, while still allowingsufficient space for the folded-over region of the cuff 1625 to remainin contact with the lumen wall, helping to form a seal about the flowcontrol device 110. Preferably, the frame envelope will conform to thelumen internal diameter where the flow control device 110 is implanted.However if there are gaps between the frame envelope and the lumeninterior wall, then the cuff 1625 is capable of providing the fluidseal.

[0178] In one embodiment, the rivets are installed onto the flow controldevice 110 by first sliding the flow control device 110 over a dimpledmandrel. A hole is then drilled through the two walls of the cuff 1625,and the hole is filled with a glue, such as silicone adhesive, whichwill dry within the hole to form the rivets. The hole in the mandrel canhave a dimpled shape that forms the inside rivet heads, while the outerheads can be formed by applying excessive adhesive on the outside. Theassembly is then cured in an oven and slid off the mandrel.

[0179] In an alternative embodiment, the cuff 1625 may have a lengthsuch that the cuff 1625 folds over the entire length of the frame 625.The cuff 1625 is reattached to the proximal end of the polymer valve,such that the frame 625 is completely enclosed by the cuff 1625, so asthe frame 625 is implanted within the bronchial passageway, the loosefolds of the polymer skirt can provide a sealing feature.

[0180] FIGS. 22-24 show yet another embodiment of a flow control device110. The flow control device 110 shown in FIGS. 22-24 is structurallysimilar to the flow control device 110 described above with reference toFIGS. 19-21 in that it includes a seal member 615 with a cuff 1625 andflanges 620. The cuff 1625 retains an anchor member 618 comprised of aframe 625. The flow control device 110 of FIGS. 22-24 also includes avalve member 612 comprised of a one-way duckbill valve 1910. Theduckbill valve 1910 is configured to prevent fluid flow from a proximalside to the distal side of the flow control device 110, and to allowflow at a controlled cracking pressure from the distal side to theproximal side through a slit 1920 (shown in FIG. 24) in the valve 1910.The cracking pressure of the duckbill valve 1910 can be adjusted bychanging the thickness of the material used to manufactured the valve1910, the durometer of the material, the angle of the duckbill valve,etc. The duckbill valve can be manufactured a deformable elastomermaterial, such as silicone.

[0181] As shown in FIGS. 22-24, the flow control device has valvedilation member 1930 that facilitates the passage of a dilation device(such as any of the dilation devices described above) through the flowcontrol device 110. As was previously described, the presence of thedilation device in the flow control device 110 can allow the passage offluid or other treatment devices to or from the isolated distal lungregion when the flow control device 110 is implanted in a bronchialpassageway. As best shown in FIGS. 22 and 24, the valve dilation member1930 defines an interior region 1935 that has a cone shape having anapex that is adjacent to an apex of the duckbill valve 1910. The outersurfaces of the valve dilation member 1920 are not sealed from thesurrounding environment, but are rather exposed. Thus, air pressure ofthe surrounding environment is equally distributed on all sides of thevalve dilation member 1930 so that the dilation member 1930 will notopen to fluid flow moving in a distal direction (such as during normalinspiration), but can be mechanically opened by a dilation device suchas a catheter.

[0182] The flow control device 110 is shown in FIG. 24 with an optionalfeature comprised of a valve protector sleeve 1938 that at leastpartially surrounds the valve dilation member 1935. The valve protectorsleeve 1938 can be attached to the seal member 615 and can made of abiocompatible materials such as stainless steel, Nitinol, etc. In orderto ensure that the cracking pressure in the distal direction is notaffected by the addition of the valve dilation member 1930, theprotector sleeve 1938 preferably has one or more vent holes 1940, whichensure that the pressure is the same on interior and exterior surfacesof the valve dilation member 1930, as well as on the proximal surface ofthe duckbill valve 1910. In this way, the cracking pressure in theproximal direction is also unaffected.

[0183]FIG. 25 shows another embodiment of the flow control device 110implanted within a bronchial passageway 910. This embodiment isstructurally similar to the embodiment shown in FIGS. 22-24, except thatthe anchor member 618 comprises a frame 625 that is distally disposed onthe flow control device 110 in the manner described above with respectto the embodiments shown in FIGS. 9-18. That is, the flow control device110 shown in FIG. 25 does not have a cuff that attaches the frame to theflow control member. Rather, the frame 625 is distally separated fromthe flow control device 110. As shown in FIG. 25, the flow controldevice 110 includes a valve protector sleeve 1938 that is attached to aproximal end of the valve dilation member 1930. As discussed, theprotector sleeve 1938 can have one or more vent holes, which ensure thatthe pressure is the same on interior and exterior surfaces of the valvedilation member 1930.

[0184]FIG. 26 illustrates another embodiment of the flow control device110 that is similar to the embodiment shown in FIG. 25. However, thevalve dilation member 1930 has no external support other than itsattachment to the duckbill valve 1910. In addition, the duckbill valve1910 is integrally attached to the seal member 615, although it shouldbe appreciated that the duckbill valve and seal member could also bemolded as two separate components and bonded together. FIG. 27 shows theflow control device 110 of FIG. 26 with a dilator device comprised of adilation catheter 2415 dilating the flow control device 110 through thevalve dilation member 1930. The dilation catheter 2415 was inserted fromthe proximal side of the flow control device 110 for use in passingfluid to or from the distal side, or for performing other therapeuticprocedures, as described below.

[0185]FIG. 28 shows yet another embodiment of the flow control device110. In this embodiment, the duckbill valve 1910 and the valve dilationmember 1930 are surrounded entirely by the annular wall 608.

[0186]FIG. 29 shows yet another embodiment of the flow control device110. The flow control device 110 of FIG. 29 includes a sealed chamber2610 that is defined by a space between the duckbill valve 1910, thevalve dilation member 1930, and the annular wall 608. This structureresults in a controlled cracking pressure for flow from the proximalside 602 to the distal side 604 of the flow control device 110 inaddition to a controlled cracking pressure for flow from the distal side604 to the proximal side 602. The cracking pressure in either directionis a function of the pressure in the sealed chamber 2610, the durometerof the material used to fabricate the duckbill valve and the valvedilation member, the thickness of the material, the included angle ofthe cone portion of the valve member 1910/valve dilation member 1930,etc. In addition, this device allows the passage of dilation devices inthe distal direction.

[0187]FIG. 30 shows yet another embodiment of the flow control device110. In this embodiment, the flow control device 110 defines twointerior lumens 2710, 2720. The flow control device 110 of FIG. 30provides for two-way fluid flow, with the interior lumen 2710 providingfor fluid flow in a first direction and the interior lumen 2720providing for fluid flow in a second direction. There is a first one-wayduckbill valve 2725 a mounted in the interior lumen 2710 that allowsfluid flow in a proximal direction and a second duckbill valve 2725 bmounted in the interior lumen 2720 that allows fluid flow in a distaldirection. This allows for different cracking pressures for fluid flowin either direction.

[0188]FIG. 31 shows another embodiment of a flow control device 110 thatpermits controlled fluid flow in either a proximal direction or a distaldirection. The flow control device 110 has a single interior lumen 2810.The flow control device 110 includes a first valve member comprised of aflap valve 2815 that is configured to permit fluid flow through thelumen 2810 in a first direction when the valve is exposed to a firstcracking pressure. A second valve 2820 permits fluid flow in a seconddirection through the lumen at a second cracking pressure.

[0189] Cracking Pressure

[0190] The cracking pressure is defined as the minimum fluid pressurenecessary to open the one-way valve member in a certain direction, suchas in the distal-to-proximal direction. Given that the valve member ofthe flow control device 110 will be implanted in a bronchial lumen ofthe human lung, the flow control device 110 will likely be coated withmucus and fluid at all times. For this reason, the cracking pressure ofthe valve is desirably tested in a wet condition that simulates theconditions of a bronchial lumen. A representative way of testing thevalve member is to use a small amount of a water based lubricant to coatthe valve mouth. The testing procedure for a duckbill valve is asfollows:

[0191] 1. Manually open the mouth of the valve member, such as bypinching the sides of the valve together, and place a drop of a dilutewater based lubricant (such as Liquid K-Y Lubricant, manufactured byJohnson & Johnson Medical, Inc.) between the lips of the valve.

[0192] 2. Wipe excess lubricant off of the valve, and force 1 cubiccentimeter of air through the valve in the forward direction to push outany excess lubricant from the inside of the valve.

[0193] 3. Connect the distal side of the valve to an air pressuresource, and slowly raise the pressure. The pressure is increased from astarting pressure of 0 inches H2O up to a maximum of 10 inches H2O overa period of time (such as 3 seconds), and the peak pressure is recorded.

[0194] This peak pressure represents the cracking pressure of the valve.

[0195] The smaller the duckbill valve, the higher the cracking pressurethat is generally required to open the valve. The cracking pressure ofsmall valves generally cannot be reduced below a certain point as thevalve will have insufficient structural integrity, as the wall thicknessof the molded elastomer is reduced, and the durometer is decreased. Forthe flow control device 110, the lower the cracking pressure is thebetter the performance of the implant.

[0196] In one embodiment, the cracking pressure of the valve member isin the range of approximately 2.6-4.7 inches H2O. In another embodiment,wherein the valve is larger than the previously-mentioned embodiment,the cracking pressure of the valve is in the range of 1.7-4.5 inchesH2O. In yet another embodiment, wherein the valve is larger than thepreviously-mentioned embodiment, the cracking pressure of the valve isin the range of 2.0-4.1 inches H2O. In yet another embodiment, whereinthe valve is larger than the previously-mentioned embodiment, thecracking pressure of the valve is in the range of 1.0-2.7 inches H2O.The cracking pressure of the valve member can vary based on variousphysiological conditions. For example, the cracking pressure could beset relative to a coughing pressure or a normal respiration pressure.For example, the cracking pressure could be set so that it is higher (orlower) than a coughing pressure or normal respiration pressure. In thisregard, the coughing or normal respiration pressure can be determinedbased on a particular patient, or it could be determined based onaverage coughing or normal respiration pressures.

[0197] Delivery System

[0198]FIG. 32 shows a delivery system 2910 for delivering and deployinga flow control device 110 to a target location in a bronchialpassageway. The delivery system 2910 includes a catheter 2915 having aproximal end 2916, and a distal end 2917 that can be deployed to atarget location in a patient's bronchial passageway, such as through thetrachea. The catheter 2915 has an outer member 2918 and an inner member2920 that is slidably positioned within the outer member 2918 such thatthe inner member 2920 can slidably move relative to the outer member2918 along the length of the catheter 2915.

[0199] In this regard, an actuation member, such as a two-piece handle2925, is located at the proximal end 2916 of the catheter 2915. Thehandle 2925 can be actuated to move the inner member 2920 relative tothe outer member 2918 (and vice-versa). In the illustrated embodiment,the handle 2925 includes a first piece 2928 and a second piece 2930,which is slidably moveable with respect to the first piece 2928. Theinner member 2920 of the catheter 2915 can be moved relative to theouter member 2918 by slidably moving the first piece 2928 of the handle2925 relative to the second piece 2930. This can be accomplished, forexample, by attaching the proximal end of the catheter inner member 2920to the first piece 2928 of the handle 2925 and attaching the proximalend of the catheter outer member 2918 to the second piece 2930. Theactuation member could also take on other structural forms that useother motions to move the inner member 2920 relative to the outer member2918. For example, the actuation member could have scissor-like handlesor could require a twisting motion to move the inner member 2920relative to the outer member 2918.

[0200] As shown in FIG. 32, the handle 2925 also includes a lockingmechanism 2935 for locking the position of the first piece 2928 relativeto the second piece 2930 to thereby lock the position of the innermember 2920 of the catheter 2915 relative to the outer member 2918. Thelocking mechanism 2935 can comprise, for example, a screw or some othertype of locking mechanism that can be used to lock the position of thefirst piece 2928 of the handle 2925 relative to the second piece 2930.

[0201] The outer member 2918, and possibly the inner member 2920, caninclude portions of differing stiffness to allow discrete portions ofthe members to bend and deflect more easily than other portions. In oneembodiment, the distal portion of the catheter 2915, for example, thelast 10 cm or so just proximal to a distally-located housing 2940, canbe made to have a reduced bending stiffness. This would allow the distalend 2917 of the catheter 2915 to bend easily around angles created bybranches in the bronchial tree, and could make placement of flow controldevices easier in more distal locations of the bronchial tree.

[0202] The outer member 2918 of the catheter 2915 could also includewire reinforcing to improve certain desired characteristics. The outermember 2918 could be manufactured to include wire winding or braiding toresist kinking, wire braiding to improve the ability of the catheter2915 to transmit torque, and longitudinal wire or wires to improvetensile strength while maintaining flexibility, which can improve devicedeployment by reducing recoil or “springiness” in the outer member 2918.The inner member 2920 could also include wire reinforcing, such as wirewinding, wire braiding, or longitudinal wire(s) to resist kinking andadd compressive strength to the inner member 2920.

[0203] With reference still to FIG. 32, a housing 2940 is located at ornear a distal end of the catheter 2915. The housing 2940 is attached toa distal end of the outer member 2918 of the catheter 2915 but notattached to the inner member 2920. As described in more detail below,the housing 2940 defines an inner cavity that is sized to receive theflow control device 110 therein. FIG. 33 shows an enlarged, perspectiveview of the portion of the distal portion of the catheter 2915 where thehousing 2940 is located. FIG. 34 shows a plan, side view of the distalportion of the catheter 2915 where the housing 2940 is located. As shownin FIGS. 33 and 34, the housing 2940 is cylindrically-shaped and is openat a distal end and closed at a proximal end. The inner member 2920 ofthe catheter 2015 protrudes through the housing and can be slidablymoved relative to the housing 2940. An ejection member, such as a flange3015, is located at a distal end of the inner member 2920. As describedbelow, the ejection member can be used to eject the flow control device110 from the housing 2940. The flange 3015 is sized such that it can bereceived into the housing 2940. The housing can be manufactured of arigid material, such as steel.

[0204] In one embodiment, a tip region 3020 is located on the distal endof the inner member 2920, as shown in FIGS. 33 and 34. The tip region3020 can be atraumatic in that it can have a rounded or cone-shaped tipthat facilitates steering of the catheter 2915 to a desired bronchialpassageway location. The atraumatic tip region 3020 preferably includesa soft material that facilitates movement of the atraumatic tip region3020 through the trachea and bronchial passageway(s). In this regard,the atraumatic tip region 3020 can be manufactured of a soft material,such as polyether block amide resin (Pebax), silicone, urethrane, andthe like. Alternately, the tip region 3020 can be coated with a softmaterial, such as any of the aforementioned materials.

[0205] The inner member 2920 of the catheter 2915 can include a centralguide wire lumen that extends through the entire length of the catheter2915, including the atraumatic tip region 3020, if present. The centralguide wire lumen of the inner member 2920 is sized to receive a guidewire, which can be used during deployment of the catheter 2915 to guidethe catheter 2915 to a location in a bronchial passageway, as describedmore fully below.

[0206] In an alternative embodiment of the catheter 2915, the catheter2915 could be fitted with a short length of flexible, bendable guidewire on the distal end of the catheter 2915. The bendable guide wirecould be used to ease the passage of the catheter 2915 through thebronchial anatomy during deployment of the catheter 2915. The fixedguide wire could include a soft, flexible atraumatic tip. The wireportion could be deformed into various shapes to aid in guiding thecatheter 2915 to the target location. For example, the wire could bebent in a soft “J” shape, or a “hockey stick” shape, and thus the tip ofthe guide wire could be directed to one side or another by rotating thecatheter 2915, thereby allowing the catheter 2915 to be guided into abranch of the bronchial tree that diverts at an angle away from the mainpassage.

[0207] In another embodiment similar to that detailed above, the distalportion of the delivery catheter 2915, proximal to the housing 2940,could be made deformable. This would allow the distal end of thecatheter 2915 to be shaped, thus allowing the catheter 2915 to be guidedinto a bronchial side branch by rotating the catheter shaft.

[0208] The delivery catheter 2915 could be modified to add a steerabledistal tip function, such as by adding a “pull” wire located inside anew lumen in the outer member 2918 of the delivery catheter 2915. Theproximal end of the pull wire would be attached to a-movable controlthat allows tension to be applied to the wire. The distal end of thewire would be terminated at a retainer attached to the distal end of theouter member 2918 of the catheter 1915. The distal portion of thecatheter 1915 could be manufactured to be much more flexible than therest of the catheter 2915, thus allowing the distal end of the catheter2915 to bend more easily than the rest of the catheter 2915. This distalportion could also have some elastic restoring force so that it willreturn on its own to a straight configuration after the tip is deflectedor the shape of the tip is disturbed. When the moveable control isactuated, thus applying tension to the pull wire, the distal tip ordistal portion of the catheter 2915 will deflect. In addition, otherways of constructing steering tips for this delivery catheter could beused.

[0209] An alternate embodiment of the steerable delivery catheter 2915is one where the distal tip or distal region of the delivery catheter2915 is permanently deformed into a bent shape, with the bent shapecorresponding with the greatest desired deflection of the distal tip.The outer member 2918 of the delivery catheter can have an additionallumen running along one side, allowing a rigid or semi-rigid mandrel orstylet to be inserted in the lumen. If the mandrel is straight, as it isinserted into the side lumen of the catheter 2915, the deformed tip ofthe catheter 2915 will progressively straighten as the mandrel isadvanced. When the mandrel is fully inserted, the outer shaft of thecatheter 2915 also becomes straight. The catheter 2915 can be insertedinto the patient in this straight configuration, and the mandrel can bewithdrawn as needed to allow the tip to deflect. In addition, themandrel or stylet could be formed into different shapes, and thecatheter 2915 would conform to this shape when the mandrel is insertedinto the side lumen.

[0210] As mentioned, the housing 2940 defines an interior cavity that issized to receive the flow control device 110. This is described in moredetail with reference to FIG. 35A, which shows a cross-sectional view ofthe housing 2940 with a flow control device 110 positioned within thehousing 2940. For clarity of illustration, the flow control device 110is represented as a dashed box in FIG. 35A. The housing 2940 can besufficiently large to receive the entire flow control device 110 withoutany portion of the flow control device protruding from the housing 2940,as shown in FIG. 35A.

[0211] Alternately, the housing 2940 can be sized to receive just aportion of the flow control device 110. For example, the distal end 604of the flow control device 110 can be shaped as shown in FIG. 35B, butcan protrude out of the housing 2940 when the flow control device 110 ispositioned within the housing 2940. In such a case, the distal end 604of the flow control device 110 can be made of an atraumatic material toreduce the likelihood of the distal end 604 damaging a body passagewayduring deployment.

[0212] Alternately, or in combination with the soft material, the distalend can be tapered so that it gradually reduces in diameter movingdistally away from the housing, such as is shown in FIG. 35B. Thetapered configuration can be formed by a taper in the shape of thedistal edge of the cuff, if the flow control device 110 has a cuff. Or,if the distal edge of the flow control device 110 is a frame, then theframe can be shaped to provide the taper. As shown in FIG. 35B, thetapered configuration of the distal end 604 of the flow control device110 can provide a smooth transition between the outer diameter of thedistal end 3020 of the catheter inner member 2920 and the outer diameterof the distal edge of the housing 2940. This would eliminate sharptransitions in the delivery system profile and provide for smoothermovement of the delivery system through the bronchial passageway duringdeployment of the flow control device 110. The housing 2940 preferablyhas an interior dimension such that the flow control device 110 is in acompressed state when the flow control device 110 is positioned in thehousing 2940.

[0213] As shown in FIGS. 35A,B, the flow control device 110 abuts or isadjacent to the flange 3015 of the catheter inner member 2920 when theflow control device is positioned within the housing 2940. As mentioned,the catheter inner member 2920 is moveable relative to the housing 2940and the catheter outer member 2918. In this regard, the flange 3015 canbe positioned to abut a base portion 3215 of the housing 2940 so thatthe flange 3015 can act as a detent for the range of movement of thecatheter inner member 2920 relative to the catheter outer member 2918.

[0214] As described in more detail below, the catheter 2915 can be usedto deliver a flow control device 110 to a desired bronchial passagewaylocation. This is accomplished by first loading the flow control deviceinto the housing 2940 of the catheter 2915. The distal end of thecatheter 2915 is then deployed to the desired bronchial passagewaylocation such that the housing (and the loaded flow control device 110)are located at the desired bronchial passageway location. The flowcontrol device 110 is then ejected from the housing 2940.

[0215] The ejection of the flow control device 110 from the housing 2940can be accomplished in a variety of ways. For example, as shown in FIG.36A, the catheter 2915 is deployed to a target location L of a bronchialpassageway 3310. The catheter handle 2925 is then actuated to move theouter catheter member 2918 in a proximal direction relative to thelocation L, while maintaining the location of the flow control device110, inner member 2920, and flange 3015 fixed with respect to thelocation L. The proximal movement of the outer member 2918 will causethe attached housing 2940 to also move in a proximal direction, whilethe flange 3015 will act as a detent that prevents the flow controldevice 110 from moving in the proximal direction. This will result inthe housing 2940 sliding away from engagement with the flow controldevice 110 so that the flow control device 110 is eventually entirelyreleased from the housing 2940 and implanted in the bronchialpassageway, as shown in FIG. 36B. In this manner, the flow controldevice 110 can be implanted at the location L where it was originallypositioned while still in the housing 2940.

[0216] According to another procedure for ejecting the flow controldevice 110 from the housing, the catheter 2915 is implanted to alocation L of a bronchial passageway 3310, as shown in FIG. 36A. Thecatheter handle 2925 is then actuated to move the inner catheter member2920 (and the attached flange 3015) in a distal direction relative tothe location L, while maintaining the location of the outer member 2918and the housing 2940 fixed with respect to the location L. The distalmovement of the flange 3015 will cause the flange 3015 to push the flowcontrol device 110 in a distal direction relative to the location L,while the location of the housing 2940 will remain fixed. This willresult in the flow control device 110 being ejected from engagement withthe housing 2940 so that the flow control device 110 is eventuallyentirely released from the housing 2940 and implanted in the bronchialpassageway distally of the original location L, as shown in FIG. 37.

[0217] Loader System

[0218] As discussed above, the flow control device 110 is in acompressed state when it is mounted in the housing 2940 of the deliverycatheter 2915. Thus, the flow control device 110 should be compressed toa smaller diameter prior to loading the flow control device 110 into thehousing 2940 so that the flow control device 110 can fit in the housing.FIG. 38 shows a perspective view of one embodiment of a loader system3510 for compressing the flow control device 110 to a smaller diameterand for inserting the flow control device 110 into the delivery catheterhousing 2940. The loader system 3510 can be used to securely hold thecatheter housing 2940 in place and to properly align the housing 2940relative to the flow control device 110 during insertion of the flowcontrol device 110 into the housing 2940. This facilitates a quick andeasy loading of the flow control device 110 into the housing 2940 andreduces the likelihood of damaging the flow control device 110 duringloading.

[0219] The loader system 3510 includes a loader device 3515 and a pusherdevice 3520. As described in detail below, the loader device 3515 isused to compress the flow control device 110 to a size that can fit intothe housing 2940 and to properly align the flow control device 110 withthe housing 2940 during insertion of the flow control device 110 intothe housing 2940. The pusher device 3520 is configured to mate with theloader device 3515 during loading, as described more fully below. Thepusher device 3520 is used to push the flow control device 110 into theloader device 3515 and into the housing 2940 during loading, asdescribed in more detail below.

[0220]FIG. 39 is a schematic, cross-sectional view of the loader device3515. A loading tunnel 3610 extends entirely through a main body of theloader device 3515 so as to form a front opening 3615 and an opposedrear opening 3620. The loading tunnel 3610 can have a circularcross-sectional shape, although it should be appreciated that theloading tunnel 3610 could have other cross-sectional shapes. The loadingtunnel 3610 has three regions, including a funnel-shaped loading region3622, a housing region 3630, and a catheter region 3635. The loadingregion 3622 of the loading tunnel 3610 gradually reduces in diametermoving in a rearward direction (from the front opening 3615 toward therear opening 3620) so as to provide the loading region 3622 with afunnel shape. The housing region 3630 has a shape that substantiallyconforms to the outer shape of the catheter housing 2940 so that thecatheter housing 2940 can be inserted into the housing region 3630, asdescribed below. The catheter region 3635 is shaped to receive the outermember 2918 of the catheter 2915.

[0221] The loader device 3515 can also include a catheter lockingmechanism 3640 comprised of a door 3645 that can be opened to providethe catheter 2915 with access to the housing region 3630 of the loadingtunnel 3610. The door 3645 can be manipulated to vary the size of therear opening 3620 to allow the housing 2940 to be inserted into thehousing region 3630, as described in more detail below.

[0222]FIG. 40 shows a perspective view of a first embodiment of thepusher device 3520. Additional embodiments of the pusher device 3520 aredescribed below. The pusher device 3520 has an elongate shape andincludes at least one piston 3710 that is sized to be axially-insertedinto at least a portion of the loading region 3622 of the loader deviceloading tunnel 3610. The piston 3710 can have a cross-sectional shapethat substantially conforms to the cross-sectional shape of the loadingregion 3622 in order to facilitate insertion of the piston 3710 into theloading region 3622. In one embodiment, the piston has one or moreregistration grooves 3715 that conform to the shape of correspondingregistration grooves 3530 (shown in FIG. 38) in the loading tunnel 3610.When the grooves 3715, 3530 are used, the piston 3710 can be insertedinto the loading tunnel 3610 of the loader device 3515 by aligning andmating the grooves to one another prior to insertion. The registrationgrooves 3715, 3530 can be used to ensure that the piston 3710 can onlybe inserted into the tunnel in a predetermined manner.

[0223] With reference to FIGS. 41-44, the loader device 3515 is used incombination with the pusher device 3520 to compress the flow controldevice 110 and insert the flow control device 110 into the housing 2940of the catheter 2915. As shown in FIG. 41, the delivery catheter 2915 ismated to the loader device 3515 such that the housing 2940 is positionedwithin the housing region 3630 of the loader device loading tunnel 3610and the catheter 2915 is positioned within the catheter region 3635 ofthe loading tunnel 3610. When properly mated, the catheter housing 2940is fixed in position relative to the loading region 3622 of the loadingtunnel 3610. (A process and mechanism for mating the delivery catheter2915 to the loader device 3515 is described below.) Furthermore, whenthe housing 2940 is positioned within the housing region 3630, thehousing interior cavity is open to the loading region 3622 of the loaderdevice 3515, such that the open end of the housing 2940 is registeredwith a rear edge of the loading region 3622.

[0224] With reference still to FIG. 41, after the catheter 2915 is matedwith the loader device 3615, the flow control device 110 is positionedadjacent the front opening 3615 of the loading region 3622 of the loaderdevice 3515. As shown in FIG. 41, the front opening 3615 is sufficientlylarge to receive the flow control device 110 therein without having tocompress the size of the flow control device 110. Alternately, a slightcompression of the flow control device 110 can be required to insert theflow control device 110 into the opening 3615. The pusher device 3520 isthen positioned such that an end 3810 of the piston 3710 is locatedadjacent to the flow control device 110. The housing 2940, flow controldevice 110 and the piston 3710 are preferably all axially aligned to acommon longitudinal axis 3711 prior to loading the flow control device110 into the housing 2940. However, even if these components are not allaxially aligned, the structure of the loader device 3515 will ensurethat the components properly align during the loading process.

[0225] With reference now to FIG. 42, the piston 3710 of the pusherdevice 3520 is then used to push the flow control device into theloading region 3622 of the loading tunnel 3610 through the front opening3615 in the tunnel. In this manner, the flow control device 110 movesthrough the loading tunnel 3610 toward the housing 2940. As thishappens, the funnel-shape of the loading region 3622 will cause the flowcontrol device 110 to be gradually compressed such that the diameter ofthe flow control device is gradually reduced as the flow control device110 moves toward the housing 2940. The walls of the loading tunnel 3610provide an equally balanced compressive force around the entirecircumference of the flow control device 110 as the flow control deviceis pushed through the loading tunnel 3610. This reduces the likelihoodof deforming the flow control device during compression.

[0226] As shown in FIG. 43, as the flow control device is pushed towardthe housing 2940, the flow control device 110 will eventually becompressed to a size that permits the flow control device to be pushedinto the housing 2940. In one embodiment, the loading region 3622 of theloading tunnel 3610 reduces to a size that is smaller than the openingof the housing 2940 so that the flow control device 110 can slide easilyinto the housing 2940 without any snags. Alternately, the opening in thehousing 2940 can be substantially equal to the smallest size of theloading region 3625.

[0227] As shown in FIG. 44, the pusher device 3520 continues to push theflow control device 110 into the loader device 3515 until the entireflow control device 110 is located inside the housing 2940. The pusherdevice 3520 can then be removed from the loader device 3515. Thecatheter 2915 and the housing 2940 (which now contains the loaded flowcontrol device 110) can then also be removed from the loader device3515.

[0228] As mentioned above, the loader device 3515 includes a lockingmechanism 3640 that is used to lock and position the catheter 2915 andcatheter housing 2940 relative to loader device 3515 during loading ofthe flow control device 110 into the housing 2940. An exemplary lockingmechanism 3640 is now described with reference to FIGS. 45-48, althoughit should be appreciated that other types of locking mechanisms andother locking procedures could be used to lock and position the catheter2915 and catheter housing 2940 relative to loader device 3515 duringloading.

[0229] As mentioned, the locking mechanism can comprise a door 3645 thatcan be moved to facilitate insertion of the catheter housing 2940 intothe loader device 3515. Such a locking mechanism 3640 is described inmore detail with reference to FIG. 45, which shows an exploded, rear,perspective view of the loading member 3515. The locking mechanism 3640comprises a door 3645 that is pivotably-attached to a rear surface ofthe loader device 3515 by a first pin 4210. A second pin 4215 alsoattaches the door 3645 to the loader device 3515. The second pin extendsthrough an arc-shaped opening 4220 in the door 3645 to provide a rangeof pivotable movement for the door 3645 relative to the loader device3515, as described more fully below. The rear surface of the loaderdevice 3515 has an opening 4230 that opens into the housing region 3630of the loading tunnel 3610 in the loader device 3515. When mounted onthe loader device 3515, the door 3645 can partially block the opening4230 or can leave the opening unblocked, depending on the position ofthe door 3645. The door 3645 includes an irregular shaped entry port4235 through which the catheter 2915 and catheter housing 2940 can beinserted into the opening 4230.

[0230]FIG. 46 shows a rear view of the loader device 3515 with the door3645 in a default, closed state. When in the closed state, the doorpartially occludes the opening 4235. The entry port 4230 includes acatheter region 4310 that is sized to receive the outer member 2918 ofthe catheter 2915. The catheter region 4310 is aligned with a centralaxis A of the opening 4230 in the loader device 3515 when the door 3645is closed. As shown in FIG. 47, the door 3645 can be moved to an openposition by rotating the door 3645 about an axis defined by the firstpin 4210. When the door is in the open position, the entry port 4230 ispositioned such that a large portion of the entry port 4230 is alignedwith the opening 4235 in the loader device 3515 so that the opening 4230is unblocked. This allows the housing 2940 of the catheter 2915 to beinserted into the housing region 3630 through the aligned entry port4230 and opening 4235 while the door 3645 is in the open position, asshown in FIG. 48A. The door 3645 can then be released and returned tothe closed position, such that the door 3645 partially blocks theopening 4230 and thereby retains the housing 2940 within the housingregion 3630, as shown in FIG. 48B. The door 3645 can be spring-loaded sothat it is biased toward the closed position.

[0231] As discussed above, during loading of the flow control device110, the flow control device 110 is initially positioned within theloading tunnel 3610 of the loader device 3515. The initial positioningof the flow control device 110 can be facilitated through the use of aloading tube 4610, shown in FIG. 49, which is comprised of a handle 4615and an elongate tube region 4620 having a diameter that can fit withinthe internal lumen of the flow control device 110. The elongate tuberegion 4620 can be hollow so as to define an interior lumen that can fitover the front nose region 3020 (shown in FIGS. 33 and 50A) of thecatheter 2915. The loading tube 4610 is used as follows: the flowcontrol device 110 is first mounted on the tube region 4620 by insertingthe tube region 4620 into the interior lumen of the flow control device110, such as is shown in FIG. 50A. The tube region 4620 can optionallyhave an outer diameter that is dimensioned such that the tube regionfits somewhat snug within the interior lumen of the flow control device110 so that the flow control device 110 is retained on the tube region4620 through a press-fit.

[0232] As shown in FIG. 50B, the loading tube 4610 is then used toinsert the flow control device 110 over the tip region 3020 and into thetunnel of the loader device 3515. The handle 4615 can be grasped by auser to easily manipulate the positioning of the flow control device 110relative to the loader device 3515. The loading tube 4610 can then beremoved from the flow control device 110 while keeping the flow controldevice 110 mounted in the loader device 3515 in an initial position. Thepusher device 3715 is then used to push the flow control device 110entirely into the loader device 3515, as was described above withreference to FIGS. 4144.

[0233]FIG. 51 shows another embodiment of the pusher device 3520, whichis referred to using the reference numeral 3520 a. The pusher device3520 a includes three separate pistons 3715 a, 3715 b, 3715 c that eachextend radially outward from a center of the pusher device 3520 in apinwheel fashion. Each of the pistons 3715 a, 3715 b, 3715 c has adifferent length L. In particular, the piston 3710 a has a length L1,the piston 3615 b has a length L2, and the piston 3710 c has a lengthL3. The pistons 3715 a,b,c can be used in series to successively pushthe flow control device 110 to increasingly greater depths into thetunnel of the loader device 110. For example, the piston 3710 a can beused first to push the flow control device 110 to a first depth L1, asshown in FIGS. 52A and 52B. The piston 3710 b can be used next to pushthe flow control device 110 to a second depth deeper than the firstdepth. The third piston 3710 c can finally be used to push the flowcontrol device 110 entirely into the housing. The pistons 3710 a,b,c canalso have different diameters from one another. The varying diameters ofthe pistons can correspond to the varying diameter of the loading tunnelin which the piston will be inserted. For example, the piston with theshortest length can have a larger diameter, as such as piston will beinserted into the region of the loading tunnel that has a relativelylarge diameter. A large diameter will prevent the piston from beinginserted to a location of smaller diameter in the tunnel. The pistonwith the longest length can have a smaller diameter, as such a pistonwill be inserted deeper into the loading tunnel, where the diameter issmaller. In this way, the piston length and diameter can be optimizedfor insertion into a particular location of the loading tunnel. Inaddition, the use of a pusher device 3520 with pistons of varying lengthcan reduce the likelihood of pushing the flow control device into theloader device 3515 at too fast of a rate.

[0234]FIG. 53 shows another embodiment of a loader device, which isreferred to as loader device 3515 a, as well as another embodiment of acorresponding pusher device 3520, which is referred to using thereference numeral 3520 a. The loader device 3515 a has plurality ofprongs 5015 that are arranged in an annular fashion so as to define afunnel-shaped loading region 5010. Thus, the loading region 5010 isdefined by a series of prongs, rather than an internal tunnel, as in theembodiment of the loader device shown in FIG. 38. As shown in FIG. 54,the pusher device 3520 a can be inserted into the loading region 5010 ofthe loader device 3515 a to load the flow control device 110 into thehousing of the catheter 2915 when the catheter 2915 is mated with theloader device 3515 a. It should be appreciated that other structurescould be used to define the loading region of the loader device. Thepusher device 3520 a has a piston with ridges that are dimensioned tomate with the prongs 5015.

[0235] FIGS. 55-58 show another embodiment of a loader device, which isreferred to as loader device 5510. FIG. 55 shows a front, plan view ofthe loader device 5510 in an open state and FIG. 56 shows a side, planview of the 20 loader device 5510 in an open state. The loader device5510 includes a first handle 5515 and a second handle 5520. The handles5515, 5520 can be moved with respect to one another in a scissorfashion. The handles 5515, 5520 are attached to a loader head 5525. Acompression mechanism 5530 is contained in the loader head 5525. Thecompression mechanism 5530 comprises a series of cams 5549 that aremechanically-coupled to the handles 5515, 5520, as described in moredetail below.

[0236] The compression mechanism 5530 defines a loading tunnel 5540 thatextends through the loader head 5525. The cams 5549 have opposedsurfaces that define the shape of the loading tunnel 5540. In theillustrated embodiment, there are four cams 550 that define arectangular-shaped tunnel looking through the tunnel when the device inthe open state. As described below, when the handles 5515, 5520 areclosed, the cams 5549 reposition so that the loading tunnel takes on acircular or cylindrical shape, as shown in FIG. 58. In the open state,the loading tunnel 5540 can accept an uncompressed flow control device110 that has a diameter D. In alternative embodiments, the compressionmechanism 5530 may contain three, five or more cams 5549.

[0237] With reference to FIG. 56, the loader device 5510 has a pistonmechanism 5545 that includes a piston 5547 that is slidably positionedin the loading tunnel 5540. The piston 5547 is attached at an upper endto a lever 5550 that can be used to slide the piston 5547 through theloading tunnel 5540. In an alternative embodiment, the piston 5547 isadvanced manually, without the use of the lever 5550, by pushing thepiston 5547 into the loading tunnel 5540.

[0238] As mentioned, the first handle 5515 and the second handle 5520are movable with respect to one another in a scissor fashion. In thisregard, FIG. 55 shows the handles 5515, 5520 in an open state. FIG. 57shows the handles 5515, 5520 in a closed state. The movement of thehandles 5515, 5520 with respect to one another actuates the compressionmechanism 5530 by causing the cams 5549 of the compression mechanism5530 to change position and thereby change the size of the loadingtunnel 5540. More specifically, the diameter D of a flow control device110 inserted into the loading tunnel 5540 is larger when the handles5515, 5520 are open (as shown in FIG. 55) and smaller when the handles5515, 5520 are closed (as shown in FIG. 57). When the handles 5515, 5520are open, the size of the loading tunnel 5540 is sufficiently large toreceive a flow control device 110 of diameter D in the uncompressedstate.

[0239] Thus, as shown in FIG. 56, the flow control device 110(represented schematically by a box 110) can be inserted into theloading tunnel 5540. Once the flow control device 110 is inserted intothe loading tunnel 5540, the handles 5515, 5520 can be closed, whichwill cause the size of the loading tunnel 5540 to decrease. The decreasein the size of the loading tunnel 5540 will then compress the diameterof the flow control device 110, which is contained in the loading tunnel5540. The flow control device 110 is compressed to a size that willpermit the flow control device 110 to fit within the housing 2940 of thecatheter delivery system 2910 (shown in FIG. 32). When the handles 5515,5520 are closed, the loading tunnel 5540 is at its minimum size. Thecams 5549 have a shape such that when the loading tunnel 5540 is at itsminimum size, the loading tunnel 5540 preferably forms a cylinder. Theloading tunnel 5540 may also form other shapes when the device is in theclosed state, however a cylindrical shape is preferable.

[0240] With reference to FIGS. 56 and 58, the piston 5547 can then beused to push the flow control device 110 into the housing 2940. Asmentioned, the lever 5550 can be used to slidably move the piston 5547through the loading tunnel 5540. As shown in FIG. 56, when the lever5550 is in a raised position, the 10 piston 5547 is only partiallyinserted into the loading tunnel 5540. As shown in FIG. 58, the lever5550 can be moved toward the loader head 5525 to cause the piston 5547to slide deeper into the loading tunnel 5540 to a depth such that thepiston 5547 will push the flow control device 110 out of the loadingtunnel 5540. The catheter housing 2940 can be placed adjacent to theloading tunnel 5540 so that the housing 2940 can receive the flowcontrol device 110 as it is pushed out of the loading tunnel 5540 by thepiston 5547. Although FIGS. 55-58 show the piston mechanism 5545attached to the loader 5510, it should be appreciated that the pistonmechanism 5545 could be removably attached or a separate devicealtogether.

[0241] Both the second handle 5520 and the lever 5550 for operating thepiston 5547 are capable of being attached to one or more stops thatallow the user to limit the amount of compression of the loading tunnel5540 or to limit the distance the piston 5547 moves into the loadingtunnel 5540. In this manner, the loader 5510 can be set to compress aflow control device 110 to a particular size (where the stop correspondsto a desired diameter) and insertion to a particular length (where thestop corresponds to a movement of the piston 5547). It should beappreciated that the loader 5510 can also be configured such that thesecond handle 5520 can actuate both the compression mechanics as well asthe piston 5547 (or a piston substitute), such that when the secondhandle 5520 is closed to a certain point, the flow control device 110will be fully compressed. Continuing to actuate the handle 5520 willcause the flow control device 110 to be loaded into the housing 2940 ofthe catheter 2915.

[0242] The loader 5510 advantageously allows a user to compress and loadthe 10 flow control device into the housing 2940 using a single hand.The user can load the flow control device 110 into the loading tunnel5540 of the loader 5510 and then use one hand to close the handles 5515,5520, which will cause the loader 5510 to compress the flow controldevice 110 to a size that will fit within the housing 2940. The user canthen actuate the piston mechanism 5545 to eject 15 the flow controldevice 110 out of the loading tunnel 5540 and into the housing 2940.

[0243] Leaf Petal Style Flow Control Devices

[0244]FIG. 59 depicts a leaf petal style flow control device 7000. Theleaf petal style flow control device 7000 is a one-way valve isolationdevice, which includes a combined valve and sealing component 7100 thatis conical or cone-like in shape as shown in FIG. 59. The valve andsealing component 7100 shown in FIG. 59 is generally conical orcone-like in shape, but other shapes may also be used. The valve/sealcomponent 7100 is formed of a plurality of segments 7150 that overlaplike the petals of a flower. Each segment 7150 has a radial edge that isconfigured to overlap an adjacent overlapping segment 7150. The radialedge can be connected or connected to the adjacent overlapping segment7150.

[0245] The flow control device 7000 also includes a frame 7200 that isused to position the device 7000 in a bronchial lumen and to support thevalve/seal component 7100. The frame 7200 includes a central core 7225.A first set of outwardly biased deployable arms 7250 extend distallyfrom the core 7225. A second set of deployable arms 7275 extendsproximally from the core 7225. The second set of deployable arms 7275can also be outwardly biased. The leaf petal style flow control device7000 also may include a frame retainer sleeve 7300 that is used toretain outwardly biased deployable arms 7250 and that can be used toradially retract the deployable arms 7250. The frame retainer sleeve7300 is mounted coaxially over the frame 7200 and can slide along thelength of the frame 7200. The flow control device 7000 can also includea second sleeve 7400 (shown in a disengaged state for clarity) that canbe used to retain deployable arms 7275.

[0246] The isolation device 7000 is implanted in a bronchial lumen suchthat the valve/seal component 7100 engaged the bronchial lumen wall. Airand liquid can pass between the valve/seal component 7100 and thebronchial lumen wall in the exhalation direction, but when flow isreversed during inhalation, the valve/seal component 7100 is compressedagainst the bronchial lumen wall, the segments 7150 are pressed againsteach other and flow of gas or liquid in the inhalation direction isprevented.

[0247] Turning to FIG. 60, the valve/seal component 7100 is shown in anexpanded state. The valve/seal component 7100 can be constructed from aflexible material such as, for example, molded silicone. Many otherflexible materials, such as urethane, can also be used. The valve/sealcomponent 7100 is formed of a plurality of segments 7150 that overlaplike the petals of a flower. FIG. 60 shows twelve overlapping segments7150, but the valve/seal component 7100 can be formed of two, three,four, five, six, seven, eight, nine, ten, eleven, twelve or moreoverlapping segments 7150 to accommodate various sized bronchial lumensand to suit varying needs. With a valve/seal component 7100 formed ofindividual overlapping segments 7150, the segments can slide relative toone another when compressed to smaller diameters, and create a sealwithout wrinkles. The device 7000 will still vent fluid easily in theexhalation direction; however, the overlapping segments 7150 will sealagainst each other and against the bronchial lumen wall duringinhalation, thus preventing fluid from flowing past the device 7000 inthe inhalation direction. This sealing effect can be maintained across arange of bronchial lumen diameters.

[0248] Alternately, the individual overlapping segments 7150 may bejoined to each other with foldable sections 7160 as shown in FIG. 60B.The foldable section can includes a radial edge that overlaps with andconnects to an adjacent overlapping segment 7150. The foldable sections7160 are flexible enough to allow the overlapping segments 7150 to sliderelative to each other in order to maintain a seal with the bronchialwall at various bronchial wall diameters. The foldable sections 7160 actas a secondary seal to prevent the flow of fluid past the device 7000 inthe inhalation direction in the situation where the seal betweenadjacent overlapping segments 7150 is compromised. The foldable sections7160 may be formed from the same material as the overlapping segments7150, or may be formed from a different material. The foldable sectionsmay be thinner or may be formed from a lower durometer material to makethem more flexible or less stiff than the overlapping segments 7150.

[0249]FIG. 60B shows one embodiment of the foldable sections 7160 in theenlarged view 7161. In this embodiment, the foldable section 7160includes a single fold and a radial edge 7163 of the segment 7150 ispositioned to overlap with the adjacent segment 7150. The radial edge7163 can be free to slide over the adjacent segment 7150 or it can beattached to the adjacent segment. In another embodiment, shown in theview 7165 of FIG. 60B, the foldable section 7160 includes two or morefolds and the segment 7150 is integrally attached to an adjacent segment7150.

[0250] As best shown in FIGS. 61-63, the valve/seal component 7100 issupported by a frame 7200. The frame includes a first set of outwardlybiased or self-expanding deployable arms 7250 that are used to anchorthe device 7000 to the wall of a bronchial lumen. The deployable arms7250 thus serve the purpose of preventing migration of the device 7000after implantation in the bronchial lumen in either the inhalation orthe exhalation direction. The frame 7000 also includes a second set ofdeployable arms 7275, which may be self-expanding, or outwardly biasedas well. The second set of deployable arms 7275 serve at least twopurposes. The first is to further anchor the device 7000 afterimplantation in the bronchial lumen and to prevent the device frommigrating in either the inhalation or the exhalation direction. Thesecond purpose that the deployable arms 7275 serve is to support thevalve/seal component 7100 that rests against the deployable arms 7275 onthe proximal end of the frame 7200 so that the shape of the valve/sealcomponent 7100 is maintained during inhalation, thus preventing thevalve/seal component 7100 or any of the overlapping segments 7150 fromturning inside out during a rapid inhalation. The overlapping segments7150 can be bonded to the deployable arms 7275, or they can rest freelyagainst the deployable arms 7275. The frame 7200 can have as manydeployable arms 7275 as there are overlapping segments 7150 in thevalve/seal component 7100. Thus, if the valve/seal component 7100 hastwelve overlapping segments 7150 as shown in FIGS. 59-65, the frame 7200can have twelve deployable arms 7275 extending proximally to supporteach one of the overlapping segments 7150. Likewise, if the valve/sealcomponent 7100 has six overlapping segments 7150, then the frame 7200can have six deployable arms 7275 to support each of the six overlappingsegments 7150. Thus, the frame can have two, three, four, five, six,seven, eight, nine, ten, eleven, twelve or more deployable arms 7275 tomatch the number of overlapping segments 7150. Alternately, the numberof deployable arms 7275 can be different than the number of overlappingsegments 7150.

[0251] The valve/seal component 7100 can be bonded to the core section7225 of the frame 7200. The distal ends of the overlapping segments 7150can be bonded to the proximal end of the core 7225 of the frame 7200 inan overlapping configuration. This leaves the proximal ends of theoverlapping segments 7150 free to expand and contract to differentdiameters. Other retainer configurations are also suitable, as long asthe valve/seal component 7100 is supported, and migration in both theinhalation (distal) and the exhalation (proximal) directions isprevented.

[0252]FIG. 61 shows the flow control device 7000 in a fully expanded anddeployed condition. The retaining sleeve 7300 has been shifted in aproximal direction to release the outwardly biased deployable arms 7250.

[0253]FIG. 62 shows the flow control device 7000 in a partially expandedand deployed condition. In this condition, the flow control device 7000can be introduced into the bronchial lumen and advanced into position toa desired location along the length of the bronchial lumen. The retainersleeve 7300 is shown in a distalmost position along the length of theframe 7200, such that it is retaining the outwardly-biased deployablearms 7250 in a contracted condition.

[0254]FIG. 63 shows the flow control device 7000 in a completelycontracted condition. As with the condition shown in FIG. 62, the flowcontrol device 7000 as shown in FIG. 63 can be introduced into thebronchial lumen and advanced into position to a desired location alongthe length of the bronchial lumen. The retainer sleeve 7300 is shown ina distalmost position along the length of the frame 7200, such that itis retaining the outwardly biased deployable arms 7250. The secondretainer sleeve 7400, which is optional, is shown in a proximalmostposition along the length of the frame 7200, such that it is retainingthe deployable arms 7275 and the overlapping segments 7150 of thevalve/seal component 7100 in a contracted condition.

[0255] One feature of the flow control device 7000 is removability afterimplantation. FIGS. 64 and 65 show the flow control device 7000 with aretainer sleeve 7300 retaining the outwardly biased deployable arms7250, and a retainer sleeve 7400 retaining the deployable arms 7275 andthe overlapping segments 7150. Removably coupled to a receptacle, suchas, for example, a hole, in the retainer sleeve 7300 is an actuationelement, such as, for example, a rigid wire or rod 7600, that extendsproximally outside of the bronchial lumen 7500. Removably coupled to areceptacle, such as, for example, a hole, in the second retainer sleeve7400 is a second actuation element, such as, for example, a rigid wireor rod 7650, that also extends proximally outside of the bronchial lumen7500.

[0256] The actuation elements can be used to push or pull the sleeves7300, 7400. Once the flow control device 7000 is advanced into positionin the bronchial lumen, the rod 7600 can be pulled or moved in aproximal direction to slide the sleeve 7300 proximally, thus releasingthe outwardly biased deployable arms 7250. Either simultaneously,before, or after the outwardly biased deployable arms 7250 are released,the rod 7650 can be pushed or moved in a distal direction toward theretainer sleeve 7300, thus releasing the deployable arms 7275 and theoverlapping segments 7150. Described slightly differently, the motion ofmoving the two sleeves towards one another can be created by moving theends of the two rods 7600 and 7650 towards each other. In oneembodiment, not shown, this motion can be accomplished by a tool thatcan hook onto the two wires and pull them together. In any case, theresult will be a flow control device 7000 that allows exhaled air andfluid to flow out of the bronchial tube as shown in FIG. 65, butprevents the flow of air or fluid past the flow control device 7000 inthe inhalation direction.

[0257] When it is time to remove the flow control device 7000, the rod7600 can be pushed or moved distally to retract the outwardly biaseddeployable arms 7250, and the rod 7650 can be pulled or moved proximallyto retract the deployable arms 7275 and the overlapping segments 7150,thus resulting in the radial collapse of the flow control device 7000.Once collapsed, the flow control device 7000 can be pulled out of thebronchial lumen.

[0258] In another embodiment, as shown in FIGS. 61 and 62, the flowcontrol device 7000 has only one retainer sleeve 7300. A rod, not shown,is attached to it. In the insertion stage, the retainer sleeve 7300retains the outwardly biased deployable arms 7250, and in the removalstage, the retainer sleeve 7300 is moved proximally to retain thedeployable arms 7275 and the overlapping segments 7150. Alternatively,rather than using a rod, a forceps or other instrument can be used tograsp the retainer sleeve 7300 and pull it proximally to retain thedeployable arms 7275 and the overlapping segments 7150 prior to removal.

[0259] The flow control device 7000 can be compressed and constrainedinside the outer tube of a delivery catheter, such as a catheter that iscomprised of an inner tube and an outer tube. The catheter is located inthe desired implant site, and the device is released by withdrawing theouter tube while holding the inner tube in position. Once released, theflow control device 7000 expands to contact and seal against thebronchial lumen. This delivery catheter can be made small enough to beinserted through the biopsy channel of a bronchoscope. This way thebronchoscope can be used to guide the delivery catheter to the targetlocation. The catheter is then advanced into the target lumen, and theflow control device 7000 released.

[0260] Umbrella Style Flow Control Devices

[0261] Like numerals are used to refer to like components in theumbrella style flow control devices described in this section. FIGS.66-70 depict various embodiments of umbrella style flow control devices.FIGS. 66A and 66B show one embodiment of an umbrella style flow controldevice 8000. The flow control device 8000 is an “umbrella” style one-wayvalve device in that it is comprised of a frame 8100 with membranestruts 8150 (similar to the tines of an umbrella) that are covered witha thin elastomeric membrane 8200. The membrane 8200 is draped over themembrane struts 8150, thus forming the umbrella shape. The membrane 8200can be formed of a thin, approximately 0.002 inches thick, polyurethanesheet material. However, other elastomeric materials, such as silicone,may be used, and many other thicknesses, both thicker and thinner than0.002 inches, may also be used. In one embodiment, the membrane 8200 hasa durometer in the range of about 40 Shore A to about 100 Shore A. Themembrane 8200 may be bonded to the full length of the membrane struts8150 running along the inner surface of the membrane, bonded in selectedlocations along the strut 8150, or not bonded at all.

[0262] Each membrane strut 8150 is connected at a distal end to a distalhub 8300 and at a proximal end to a proximal hub 8400. The membranestruts 8150 radiate outwardly (i.e. laterally) from the distal hub 8300and the proximal hub 8400 to form a ring having a flexible diameter8500. The membrane struts 8150 can be spring biased outwardly (as shown)so that when the flow control device 8000 is implanted in a bronchiallumen, the struts bias and hold the membrane against the wall of thebronchial lumen.

[0263] In the embodiments shown in FIGS. 66A, 66B, and 67, the membranestruts 8150 are attached or bonded together at the distal hub 8300, andagain at the proximal hub 8400. When the flow control device 8000 iscompressed for loading, as shown in FIG. 66B, the two connectors moveaway from one another to allow the diameter 8500 of the device todecrease and the device 8000 to radially collapse. When the flow controldevice 8000 is released or ejected from the delivery catheter housingand allowed to expand, the membrane struts 8150 expand to their formershape and press the membrane 8200 against the bronchial lumen wall. Thestruts 8150 can have a stiffness sufficient to tension the membrane whendeployed in the bronchial lumen or sufficient to exert pressure againstthe lumen and deform the lumen into a polygonal shape. The membrane canbe sufficiently flexible to seal with the wall of the bronchial lumenwhen the membrane is not tensioned by the struts. The flow controldevice 8000 can conform to different lumen diameters, and when placed insmaller diameters, the membrane 8200 may pleat or fold to seal againstthe lumen wall during inhalation.

[0264] In another embodiment, not shown, the distal hub 8300 andproximal hub 8400 may be linked by an axial member, such as a cable,rod, or shaft, that allows the distance between the two connectors to beadjusted. In this way, the outer diameter 8500 of the device may beincreased by drawing the two connectors together, or may be reduced byspreading the connectors father apart. Accordingly, the flow controldevice 8000 may be sized to the bronchial lumen, or if desired, the loadof the struts against the bronchial lumen wall may be increased ordecreased. If the connectors are spread apart, the flow control device8000 may be collapsed for removal from the bronchial lumen.

[0265] In one embodiment, the connectors are linked by a threaded rod(not shown). The rod is captured by the distal hub 8300 but is free torotate in the distal hub 8300. The proximal hub 8400 is threaded suchthat it will translate along the threaded rod when the rod is rotated.In this manner, the outer diameter 8500 of the device 8000 may be variedby rotating the threaded rod in one direction or the other. This wouldallow the device 8000 to be collapsed for delivery without the need fora delivery catheter with a restraining housing, and could be expandedfor a good fit within the bronchial lumen by rotating the threaded rod.

[0266] Alternatively, the connectors 8300 and 8400 can be linked by aflexible member (not shown) that is fixed to the distal hub 8300, and isthreaded through the proximal hub 8400 that includes a locking feature(not shown). In this way, the device can be expanded by pulling theflexible member through the proximal hub 8400 until the device 8000expands to the desired diameter, and then locked in place at theproximal hub 8400. Of course, other adjustment members and methods arealso possible.

[0267] Fluid (gas or liquid) will flow past the flow control device 8000in the proximal direction, for example during exhalation, by flowingalong the bronchial lumen wall between the membrane struts 8150 bypushing the membrane 8200 away from the wall thus creating flow channelsbetween each pair of membrane struts 8200. When flow is reversed, forexample during inhalation, the fluid flow in the distal direction willforce the membrane 8200 against the bronchial lumen wall, thus sealingthe passage and preventing flow past the flow control device 8000. Thereare also two or more retention elements comprised of retainer struts8175 on the distal end, the proximal end (as shown in FIGS. 66A and66B), or both ends. The retention struts 8175 protrude laterally fromthe frame, For example, the retention struts 8175 can have a shape, suchas an outwardly-flared shape, that serves to grip the bronchial lumenwall to prevent migration of the flow control device 8000 in either thedistal or proximal directions. The retainer struts 8175 are shown inFIG. 66B in a deployed state, but they would be retracted if loaded intoa delivery catheter, returning to their deployed position only uponrelease from the delivery catheter. In the deployed position, theretainer struts 8175 are at an angle of approximately ninety degreesrelative to the connector 8400, though angles greater than or less thanninety degrees may be used.

[0268] Alternately, the end of the retention struts 8175 may be formedinto the shape shown in FIG. 66C. The retention strut 8175 includes anenlarged section 8177 that can be formed, for example, by bending ortwisting a portion of the retention strut 8175 to form a foot. With thisshape, the depth of penetration of the distal end 8179 of the retentionstrut 8175 into the bronchial lumen wall is limited, and will preventthe distal end 8175 of the strut from penetrating beyond a predetermineddistance into the lumen wall. In this embodiment, the retention strutend is formed from the strut material, however other configurations arepossible such as attaching a strut end to the retention strut 8175 thatis formed as a separate component.

[0269] As shown in FIGS. 66 and 67, the frame 8100 has eight membranestruts 8100, but it can have two, three, four, five, six, seven, eight,nine, ten, eleven, twelve, or more struts 8100. The struts shown in thefigures are plain end wires, however other configurations may be used.The membrane struts 8150 and the retention struts 8175 (or retentioncoil 8180) can be made of nickel-titanium alloy (such as Nitinol) wire.Nitinol can be chosen for its super-elastic properties so that the flowcontrol device 8000 can be compressed to a small diameter for insertionin a delivery catheter, yet still expand to its original shape afterdeployment. It should be appreciated that many other elastic materialswould work well including stainless steel, plastic, etc.

[0270] As mentioned above with respect to FIG. 66C, a bend in the wireend, or a foot could be attached to the retention struts to preventmigration. In an alternative embodiment, as shown in FIG. 67, theretention element comprises a retention coil 8180 that can be usedinstead of retention struts 8175 to prevent migration. The retentionspring can extend proximally from the proximal hub 8400 and can expandto fit different sized bronchial lumens.

[0271] In another embodiment, as shown in FIG. 68, the membrane struts8150 have a curved shape where they contact the membrane 8200, ratherthan the straight shape shown in the embodiments depicted in FIGS. 66A,66B, and 67. In this way, the membrane 8200 may conform more closely tothe bronchial lumen wall when placed in bronchial lumens of differentdiameters.

[0272] In another embodiment as shown in FIG. 69, pleats 8225 are formedinto the membrane 8200 between the membrane struts 8150. In thisembodiment, the pleats 8225 are pre-formed so that the shape and aspectof the pleats will be controlled in order to improve the sealingperformance of the flow control device 8000. In this embodiment, themembrane 8200 is pleated when placed in all diameters of bronchiallumens. It may also be beneficial to extend the length of the pleats8225 so that the pleat 8225 is under the adjacent membrane strut 8150 atall diameters of the device 8000. This way the membrane strut 8150 willensure that the pleat 8225 is held against the bronchial lumen wall.

[0273] In yet another embodiment as shown in FIG. 70, pre-formed pleats8225 in the membrane 8200 are supported by bends 8190 in the membranestruts 8150. The bends 8190 in the membrane struts 8150 hold the pleats8225 firmly against the wall of the bronchial lumen after placement, andthey ensure that when flow is reversed from exhalation to inhalation,the membrane seals against the bronchial lumen wall. As with the otherembodiments, the frame 8100 can have two, three, four, five, six, seven,eight, nine, ten, eleven, twelve, or more struts 8150 , each with a bend8190. Alternatively, alternating struts 8150 can have one or more bends8190. Also, the membrane 8200 can be bonded to the full length of themembrane struts 8150, or just to selected locations such as the bends8190, or not bonded at all.

[0274] The umbrella style flow control devices depicted in FIGS. 66-70,may be compressed inside a housing of a delivery catheter for deliveryinto the target bronchial lumen. As housing may be retracted, or theflow control device pushed out of the housing, in order to release thedevice in the target bronchial lumen and allow it to expand to contactthe lumen wall. Alternatively, they may be positioned in a bronchialtube with a push catheter 8195 as shown in FIGS. 66A, 66B, and 68.

[0275] Methods of Use

[0276] Disclosed is a method of deploying a flow control device 110 to abronchial passageway in order to regulate or eliminate airflow to orfrom a targeted lung region. The deployed flow control device 110 caneliminate air flow into the targeted lung region and result in collapseof the targeted lung region. However, the deployed flow control device110 need not result in the collapse of the targeted lung region in orderto gain a beneficial effect. Rather, the flow control device 110 canregulate airflow to and from the targeted lung region to achieve animproved air flow dynamic, such as by eliminating airflow into thetargeted lung region during inhalation, but not resulting in collapse.The deployment of the flow control device 110 can channel or redirectthe inhaled air to a non-isolated, healthier region of the lung, thusimproving ventilation to the healthier lung tissue, and improvingventilation-perfusion matching in the healthier lung region. The exhaledair of the targeted lung region can still be vented through theimplanted one-way flow control device 110, and thus the exhalationdynamics of the targeted lung region need not be affected by thepresence of the flow control device. This can result in an increase inthe efficiency of oxygen uptake in the lungs.

[0277] The method of deployment and treatment can be summarizedaccording to the following steps, which are described in more detailbelow. It should be appreciated that some of the steps are optional andthat the steps are not necessarily performed in the order listed below.The steps include:

[0278] (a) identifying a targeted lung region and determining a targetlocation in bronchial passageway(s) to which the flow control devicewill be deployed;

[0279] (b) determining the diameter of the target location in thebronchial passageway(s) and selecting an appropriately sized flowcontrol device for deploying in the lumen of the bronchial passageway;as described below, this step is optional, as a flow control device canbe manufactured to span a wide range of bronchial diameters so thatlumen measurement would not be necessary;

[0280] (c) loading the selected flow control device into a deliverydevice, such as the delivery catheter described above, for deliveringand deploying the flow control device to the bronchial passageway; thisstep is optional, as the flow control device can be manufactured orobtained pre-loaded in a delivery device;

[0281] (d) positioning the delivery catheter within the bronchialpassageway so that the flow control device is positioned at the targetlocation in the bronchial passageway;

[0282] (e) deploying the flow control device at the target location inthe bronchial passageway;

[0283] (f) removing the delivery device;

[0284] (g) performing one or more procedures on the targeted lung regionand/or allowing reactions to occur in the targeted lung region as aresult of the presence of the flow control device.

[0285] According to step (a), a physician or technician evaluates thediseased area of a patient's lung to determine the targeted lung regionand then determines the bronchial passageway(s) that provide airflow tothe targeted lung region. Based on this, one or more target locations ofbronchial passageways can be determined to which one or more flowcontrol devices can be deployed.

[0286] In step (b), the proper size of a flow control device forinsertion into the bronchial passageway is determined. As mentioned,this step is optional, as a flow control device can be manufactured tospan a wide range of bronchial diameters so that lumen measurement wouldnot be necessary. It should be appreciated that a precise match betweenthe size of the flow control device 110 and the lumen of the bronchialpassageway is not required, as the compressibility and expandability ofthe flow control device 110 provides a variation in size. In oneembodiment, the flow control device is selected so that its size isslightly larger than the size of the bronchial passageway.

[0287] Various methods of measuring a bronchial passageway diameter areknown and understood in the art. For example, a balloon having a knownratio of inflation to diameter can be used, thus allowing an accurateway of determining a bronchial passageway diameter. A loop or measuringdevice such as a marked linear probe may also used. The diameter couldalso be measured using a high resolution computerized tomography (CT)scan. Even an “eye-ball” estimate could also be sufficient, wherein thesizing is done visually without using a measuring tool, depending on theskill of the physician.

[0288] In step (c), the flow control device is loaded onto a deliverysystem, such as the delivery system 2910 comprised of the catheter 2915that was described above with reference to FIG. 31. If the deliverysystem 2910 is used, the flow control device 110 is loaded into thehousing 2940 at the distal end of the catheter 2915, such as by usingthe loader system 3510, described above. Alternately, the flow controldevice 110 can be loaded into the housing 2940 by hand. As mentioned,the loading step can be optional, as the flow control device 110 can bemanufactured or obtained with the flow control device pre-loaded. Itshould be appreciated that other delivery systems could also be used todeliver the flow control device to the bronchial passageway.

[0289] In step (d), the delivery catheter is inserted into the bronchialpassageway so that the flow control device 110 is positioned at adesired location in the bronchial passageway. This can be accomplishedby inserting the distal end of the delivery catheter 2915 into thepatient's mouth or nose, through the trachea, and down to the targetlocation in the bronchial passageway. The delivery of the deliverycatheter 2915 to the bronchial passageway can be accomplished in avariety of manners. In one embodiment, a bronchoscope is used to deliverthe delivery catheter 2915. For example, with reference to FIG. 59, thedelivery catheter 2915 can be deployed using a bronchoscope 5210, whichin an exemplary embodiment has a steering mechanism 5215, a shaft 5220,a working channel entry port 5225, and a visualization eyepiece 5230.The bronchoscope 5210 has been passed into a patient's trachea 225 andguided into the right primary bronchus 510 according to well-knownmethods.

[0290] It is important to note that the distal end of the bronchoscopeis preferably deployed to a location that is at least one bronchialbranch proximal to the target bronchial lumen where the flow controldevice will be implanted. If the distal end of the bronchoscope isinserted into the target bronchial lumen, it is impossible to properlyvisualize and control the deployment of the flow control device in thetarget bronchial lumen. For example, if the bronchoscope is advance intothe right primary bronchus 510 as shown in FIG. 59, the right upperlobar bronchi 517 can be visualized through the visualization eyepieceof the bronchoscope. The right upper lobar bronchi 517 is selected asthe target location for placement of a flow control device 110 and thedistal end of the bronchoscope is positioned one bronchial generationproximal of the bronchial passageway for the target location. Thus, thedistal end of the bronchoscope is deployed in the right primary bronchus510. The delivery catheter 2915 is then deployed down a working channel(not shown) of the bronchoscope shaft 5220 and the distal end 5222 ofthe catheter 2915 is guided out of the distal tip of the bronchoscopeand advanced distally until the delivery system housing containing thecompressed flow control device is located inside the lobar bronchi 517.

[0291] The steering mechanism 5215 can be used to alter the position ofthe distal tip of the bronchoscope to assist in positioning the distaltip of the delivery catheter 5222 such that the delivery catheterhousing can be advanced into the desired bronchi (in this case the lobarbronchi 517). It should be appreciated that this technique can beapplied to any desired delivery target bronchi in the lungs such assegmental bronchi, and not just the lobar bronchi.

[0292] Alternately, the delivery catheter 2915 can be fed into thebronchoscope working channel prior to deploying the bronchoscope to thebronchial passageway. The delivery catheter 2915 and the bronchoscope5210 can then both be delivered to the bronchial passageway that is onegeneration proximal to the target passageway as a single unit. Thedelivery catheter can then be advanced into the target bronchi asbefore, and the flow control device 110 delivered.

[0293] In another embodiment, the inner member 2920 of the deliverycatheter 2915 has a central guidewire lumen, so that the catheter 2915is deployed using a guidewire that guides the catheter 2915 to thedelivery site. In this regard, the delivery catheter 2915 could have awell-known steering function, which would allow the catheter 2915 to bedelivered with or without use of a guidewire. FIGS. 60-61 illustrate howthe catheter 2915 can be used to deliver the flow control device 110using a guidewire.

[0294]FIG. 60 illustrates a first step in the process of deploying adelivery catheter 2915 to a target location using a guidewire. Aguidewire 5310 is shown passed down the trachea 225 so that the distalend of the guidewire 5310 is at or near the target location 5315 of thebronchial passageway. The guidewire 5310 can be deployed into thetrachea and bronchial passageway through free wiring, wherein theguidewire 5310 with a steerable tip is alternately rotated and advancedtoward the desired location. Exchange wiring can also be used, whereinthe guidewire 5310 is advanced down the working channel of abronchoscope that has been previously deployed. The bronchoscope canthen be removed once the guidewire is at the desired location.

[0295] In any event, after the guidewire 5310 is deployed, the distalend of the delivery catheter 2915 is back loaded over the proximal endof the guidewire 5310. The delivery catheter 2915 is advanced along theguidewire 5310 until the housing 2940 on the distal end of the deliverycatheter 2915 is located at the target location 5315 of the bronchialpassageway. The guidewire 5310 serves to control the path of thecatheter 2915, which tracks over the guidewire 5310, and insures thatthe delivery catheter 2915 properly negotiates the path to the targetsite. Fluoroscopy can be helpful in visualizing and insuring that theguidewire 5310 is not dislodged while the delivery catheter is advanced.As shown in FIG. 61, the delivery catheter 2915 has been advanceddistally over the guidewire 5310 such that the housing 2940 at thedistal end of the delivery catheter 5310 has been located at the targetlocation 5315 of the bronchial passageway. The flow control device 110is now ready for deployment.

[0296] Visualization of the progress of the distal tip of the deliverycatheter 2915 can be provided by a bronchoscope that is manuallyadvanced in parallel and behind the delivery catheter 2915.Visualization or imaging can also be provided by a fiberoptic bundlethat is inside the inner member 2920 of the delivery catheter 2915. Thefiberoptic bundle could be either a permanent part of the inner member2920, or could be removable so that it is left in place while thehousing 2940 is maneuvered into position at the bronchial targetlocation, and then removed prior to deployment of the flow controldevice 110. The removable fiberoptic bundle could be a commercialangioscope which has fiberoptic lighting and visualization bundles, butunlike a bronchoscope, it is not steerable.

[0297] Passage of the delivery catheter through tortuous bronchialanatomy can be accomplished or facilitated by providing the deliverycatheter 2915 with a steerable distal end that can be controlledremotely. For example, if the distal end of the catheter 2915 could bebent in one direction, in an angle up to 180 degrees, by the actuationof a control on the handle 2925, the catheter 2915 could be advancedthrough the bronchial anatomy through a combination of adjusting theangle of the distal tip deflection, rotating the delivery catheter 2915,and advancing the delivery catheter 2915. This can be similar to the wayin which many bronchoscopes are controlled.

[0298] It can be advantageous to use a specific design of a guidewirethat configured to allow the delivery catheter 2915 to navigate thetortuous bronchial anatomy with minimal pushing force, and minimalhang-ups on bronchial carinas.

[0299] A guidewire can be constructed of a stainless steel core which iswrapped with a stainless steel coil. The coil is coated with a lubricouscoating, such as a Polytetrafluoroethylene (PTFE) coating, a hydrophiliccoating, or other lubricious coating. The guidewire can be in the rangeof, for example, around 180 cm in length and 0.035″ inch in overalldiameter, though other lengths and diameters are possible. A proximalportion of the wire core can be constructed so that after winding theouter coil onto the core, it is as stiff as possible but still allowsfor easy placement in the lungs using an exchange technique with abronchoscope. The distal portion, such as the distal-most 2-5 cm, of thewire core may be made with a more flexible construction in order tocreate an atraumatic tip to the wire. This atraumatic nature of thedistal tip can be enhanced by adding a “modified j” tip. A portion ofthe wire (such as about 3 cm) between the distal and proximal sectionscould provide a gradual stiffness transition so that the guidewire doesnot buckle when placed in the lung anatomy.

[0300] By having a relatively short atraumatic section, the cliniciancan place the guidewire in the target location of the bronchialpassageway with only a small length of guidewire extending distally ofthe target passageway. This will minimize the probability of puncturedlungs and other similar complications. The clinician can then utilizethe stiff nature of the proximal portion of the guidewire to facilitateplacing the delivery catheter all the way to the target bronchialpassageway.

[0301] With reference again to the method of use, in step (e), the flowcontrol device 110 is deployed at the target location of the bronchialpassageway. The flow control device 110 is deployed in the bronchiallumen such that the flow control device 110 will provide a desired fluidflow regulation through the bronchial lumen, such as to permit one-wayfluid flow in a desired direction, to permit two-way fluid flow, or toocclude fluid flow.

[0302] The deployment of the flow control device 110 can be accomplishedby manipulating the two-piece handle 2925 of the catheter 2915 in orderto cause the housing 2940 to disengage from the flow control device 110,as was described above with reference to FIGS. 36 and 37. For example,the handle can be actuated to withdraw the outer member of the catheterrelative to the inner member, which will cause the housing 2940 to movein a proximal direction while the flange on the inner member retains theflow control device 110 against movement within the bronchialpassageway. By withdrawing the housing instead of advancing the flange,the flow control device 110 can be deployed in the bronchial passagewayat the target location, rather than being pushed to a more distallocation. After the flow control device 110 has been deployed at thetarget site in the bronchial passageway, the delivery devices, such asthe catheter 2915 and/or guidewire, is removed in step (f).

[0303] Either all or a portion of the flow control device 110 can becoated with a drug that will achieve a desired effect or reaction in thebronchial passageway where the flow control device 110 is mounted. Forexample, the flow control device 110 can be coated with any of thefollowing exemplary drugs or compounds:

[0304] (1) Antibiotic agents to inhibit growth of microorganisms(sirolimus, doxycycline, minocycline, bleomycin, tetracycline, etc.)

[0305] (2) Antimicrobial agents to prevent the multiplication or growthof microbes, or to prevent their pathogenic action.

[0306] (3) Antiinflammatory agents to reduce inflammation.

[0307] (4) Anti-proliferative agents to treat cancer.

[0308] (5) Mucolytic agents to reduce or eliminate mucus production.

[0309] (6) Analgesics or pain killers, such as Lidocane, to suppressearly cough reflex due to irritation.

[0310] (7) Coagulation enhancing agents to stop bleeding.

[0311] (8) Vasoconstrictive agents, such as epinephrine, to stopbleeding.

[0312] (9) Agents to regenerate lung tissue such as all-trans-retinoicacid.

[0313] (10) Steroids to reduce inflammation.

[0314] (11) Gene therapy for parenchymal regeneration.

[0315] (12) Tissue growth inhibitors (paclitaxel, rapamycin, etc.).

[0316] (13) Sclerosing agents, such as doxycycline, minocycline,tetracycline, bleomycin, cisplatin, doxorubicin, fluorouracil,interferon-beta, mitomycin-c, Corynebacterium parvum,methylprednisolone, and talc.

[0317] (14) Agents for inducing a localized infection and scar, such asa weak strain of Pneumococcus.

[0318] (15) Fibrosis promoting agents, such as a polypeptide growthfactor (fibroblast growth factor (FGF), basic fibroblast growth factor(bFGF), transforming growth factor-beta (TGF-β)).

[0319] (16) Pro-apoptopic agents such as sphingomyelin, Bax, Bid, Bik,Bad, caspase-3, caspase-8, caspase-9, or annexin V.

[0320] (17) PTFE, parylene, or other lubricous coatings.

[0321] (18) In addition, the retainer and other metal components couldbe irradiated to kill mucus production or to create scar tissue.

[0322] It should be appreciated that the aforementioned list isexemplary and that the flow control device 110 can be coated with othertypes of drugs or compounds.

[0323] After the flow control device 110 is implanted, the targeted lungregion can be allowed to collapse over time due to absorption of trappedgas, through exhalation of trapped gas through the implanted flowcontrol device 110, or both. As mentioned, collapse of the targeted lungregion is not necessary, as the flow control device 110 can be used tosimply modify the flow of air to the targeted lung region. Alternately,or in addition to, allowing the targeted lung region to collapse overtime, one or more methods of actively collapsing the lung segment orsegments distal to the implanted flow control device or devices can beperformed. One example of an active collapse method is to instill anabsorbable gas through a dilation catheter placed through the flowcontrol device and very distally in the targeted lung region, while atthe same time aspirating at a location proximal to the flow controldevice 110 with a balloon catheter inflated in the proximal region ofthe flow control device 110. In another example, oxygen is instilledinto the distal isolated lung region through a catheter that dilates theflow control device 110. When this is complete, a method of activelycollapsing the isolated lung region could be performed (such asinsuflating the pleural space of the lung) to drive the gas present inthe isolated lung region out through the implanted flow control device110. One example of performing active collapse without a dilation devicepresent would be to insert a balloon into the pleural space and inflateit to force gas or liquid out of the isolated lung region and collapsethe lung.

[0324] The following is a list of methods that can be used to activelycollapse a targeted lung region that has been bronchially isolated usinga flow control device implanted in a patient's bronchial passageway:

[0325] (1) The patient is allowed to breath normally until air isexpelled from the lung segment or segments distal to the device.

[0326] (2) The targeted lung region is aspirated using a continuousvacuum source that can be coupled to a proximal end of the deliverycatheter, to a dilator device that crosses the flow control device, orto a balloon catheter placed proximally to the implanted flow controldevice.

[0327] (3) Fluid is aspirated from the targeted lung region using apulsed (rather than continuous) vacuum source.

[0328] (4) Fluid is aspirated from the targeted lung region using a verylow vacuum source over a long period of time, such as one hour or more.In this case, the catheter may be inserted nasally and a water seal maycontrol the vacuum source.

[0329] (5) The targeted lung region can be filled with fluid, which isthen aspirated.

[0330] (6) Insufflate pleural space of the lung with gas through apercutaneously placed needle, or an endobronchially placed needle, tocompress the lung.

[0331] (7) Insert a balloon into the pleural space and inflate theballoon next to targeted lung region.

[0332] (8) Insert a percutaneously placed probe and compress the lungdirectly.

[0333] (9) Insert a balloon catheter into the bronchial passagewayleading to adjacent lobe(s) of the targeted lung region and over-inflatethe adjacent lung segment or segments in order to collapse the targetedlung region.

[0334] (10) Fill the pleural space with sterile fluid to compress thetargeted lung region.

[0335] (11) Perform external chest compression in the region of thetarget segment.

[0336] (12) Puncture the targeted lung region percutaneously andaspirate trapped air.

[0337] (13) Temporarily occlude the bronchus leading to the lower lobeand/or middle lobe as the patient inhales and fills the lungs, thusincreasing compression on the target lung segment or segments duringexhalation.

[0338] (14) Induce coughing.

[0339] (15) Encourage the patient to exhale actively with pursed lipbreathing.

[0340] (16) Use an agent to clear or dilate the airways includingmucolytics, bronchodilators, surfactants, desiccants, solvents,necrosing agents, sclerosing agents, perflourocarbons, or absorbents,then aspirate through the flow control device using a vacuum source.

[0341] (17) Fill the isolated lung region with 100% oxygen (O2) or othereasily absorbed gas. This could be accomplished using a dilation device,such as a catheter, that is passed through an implanted flow controldevice. The oxygen would dilute the gas that is in the isolated lungregion to thereby raise the oxygen concentration, causing any excess gasto flow out of the isolated lung region through the flow control deviceor dilation device. The remaining gas in the isolated lung region wouldhave a high concentration of oxygen and would be more readily absorbedinto the blood stream. This could possibly lead to absorptionatelectasis in the isolated lung region. The remaining gas in theisolated lung region could also be aspirated back through the dilationdevice to aid in collapse of the isolated lung region.

[0342] Optionally, a therapeutic agent could be instilled through adilator device (such as was described above) that has been passedthrough the flow control device deployed at a target site in thepatient's bronchial lumen. The therapeutic agent is instilled into thebronchial lumen or lumens distal to the implanted flow control device.Alternately, brachytherapy source or sources could be inserted throughthe dilator device and into the lumen or lumens distal to the flowcontrol device to reduce or eliminate mucus production, to causescarring, or for other therapeutic purposes.

[0343] The patient's blood can be de-nitrogenated in order to promoteabsorption of nitrogen in trapped airways. Utilizing any of the devicesor methods above, the patient would either breath through a mask or beventilated with heliox (helium-oxygen mixture) or oxygen combined withsome other inert gas. This would reduce the partial pressure of nitrogenin the patient's blood, thereby increasing the absorption of nitrogentrapping in the lung spaces distal to the implanted flow control device.

[0344] As mentioned, one method of deflating the distal lung volumeinvolves the use of pulsed vacuum instead of continuous vacuum.Pulsatile suction is defined as a vacuum source that varies in vacuumpressure from atmospheric pressure down to −10 cm H₂O. The frequency ofthe pulse can be adjusted so that the collapsed bronchus has time tore-open at the trough of the suction wave prior to the next cycle. Thefrequency of the pulse could be fast enough such that the bronchus doesnot have time to collapse at the peak of the suction wave prior to thenext cycle. The suction force could be regulated such that even at thepeak suction, the negative pressure is not low enough to collapse thedistal airways. The frequency of the pulsatile suction could be set tothe patient's respiratory cycle such that negative pressure is appliedonly during inspiration so that the lung's tethering forces are exertedkeeping the distal airways open.

[0345] One possible method of implementing this described form ofpulsatile suction would be to utilize a water manometer attached to avacuum source. The vacuum regulator pipe in the water manometer could bemanually or mechanically moved up and down at the desired frequency tothe desired vacuum break point (0 to −10 cm). This describes only one ofmany methods of creating a pulsatile vacuum source.

[0346] At any point, the dilator device (if used) can be removed fromthe flow control device. This can be accomplished by pulling on a tetherattached to the dilator device (such as was shown in FIG. 15), pullingon a catheter that is attached to the dilator device, or grasping thedilator device with a tool, such as forceps. After removal of thedilator device, another dilator device could be used to re-dilate theflow control device at a later time.

[0347] Asymmetric Delivery Catheter

[0348] During deployment of the flow control device 110 using anover-the-wire delivery catheter, navigating the delivery catheter 2915past the lungs' carinae can frequently present difficulties, as thehousing 2940 can often get stuck against the sharp edge of a carina orwill not properly align with the ostium of a target bronchus. If thehousing 2940 gets stuck, it can be very difficult to advance thecatheter 2915 any further or to achieve a more distal placement.

[0349] In order to ease the navigation of the housing past carinae andinto the ostium of a target bronchus, the tip region 3020 of thecatheter inner member 2920 can have a rib or elongate protrusion 5810extending in one direction radially so as to provide the tip region 3020with an asymmetric shape, such as is shown in FIGS. 62 and 63. The tipregion 3020 is asymmetric with respect to a central longitudinal axis6210 of the catheter 2915. The protrusion 5810 can extend radially, forexample, as far as the outer diameter of the housing 2940. Theprotrusion 5810 extends only in one direction in order to minimize theperimeter of the tip region 3020, which facilitates passing the tipregion 3020 through the central lumen of the flow control device 110.The protrusion 5810 can be made of a solid material (such as shown inFIG. 62) or, alternately, the protrusion 5810 can be hollow (such asshown by reference numeral 6310 in FIG. 63) in order to allow somecompressive compliance. The compliance would be such that the protrusion5810 does not compress when pushed against lung tissue but wouldcompress when it is pulled through the flow control device 110 or pushedinto the lumen of a loading device.

[0350] By having the protrusion 5810 be compliant, the protrusion 5810could be tall enough to extend to the outside diameter of the housingbut then compress to a smaller size that would fit through the flowcontrol device lumen or the loading device. Alternatively, two or moreradially spaced protrusions could be added to the tip region 3020 of thecatheter 2915 to provide a smooth transition between the tip region 3020and the housing 2940. The protrusions 5810 could be made hollow or verysoft so that they would easily collapse when inserted through the flowcontrol device 110.

[0351] As mentioned, the outer shaft 2918 of the delivery catheter 2915could be shaped to contain a curve, biasing the whole catheter in onedirection. In one embodiment, shown in FIG. 64, the curve 6010, ifpresent, is contained within a single plane and is limited to a portion,such as 3 inches, of catheter length just proximal to the housing 2940.The plane of the outer shaft curve could be coincident with the planecontaining the protrusion 5810 on the tip region 3020. In this manner,the curve in the outer shaft could be used to align the deliverycatheter 2915 so that as the catheter 2915 is traveling over a curvedguidewire it will have the protrusion 5810 always facing outwardrelative to the curve. Due to the three dimensional nature of thebronchial tree in the lungs, a useful geometry of the shaped end of thecatheter may be a complex curve that bends in three dimension to matchthe lung anatomy, rather than being a simple curve in single plane (twodimensions). In addition, the proximal end of the catheter 2915 might beshaped to conform to the curve commonly found in endotracheal tubes toease delivery if the patient is under general anesthesia and is beingventilated.

[0352] Although embodiments of various methods and devices are describedherein in detail with reference to certain versions, it should beappreciated that other versions, embodiments, methods of use, andcombinations thereof are also possible. Therefore the spirit and scopeof the appended claims should not be limited to the description of theembodiments contained herein.

What is claimed:
 1. A flow control device, comprising: a sealingcomponent that can be positioned within a bronchial lumen, the sealingcomponent comprised of two or more overlapping segments that are movablerelative to one another such that the segments collectively form a sealthat can expand and contract in size to fit within and seal bronchiallumens of various sizes.
 2. A device as defined in claim 1, wherein thesealing component permits fluid flow in a first direction and preventsfluid flow in a second direction opposed to the first direction when thesealing component is located within a bronchial lumen.
 3. A device asdefined in claim 1, wherein the overlapping segments collectively form aconical shape and wherein the diameter of the conical shape can vary asone segment moves with respect to another segment.
 4. A device asdefined in claim 1, further comprising a retainer frame comprising acore and a first set of one or more deployable arms.
 5. A device asdefined in claim 4, wherein the deployable arms are laterally biased. 6.A device as defined in claim 4, wherein the two or more overlappingsegments of the sealing component are attached to the core.
 7. A deviceas defined in claim 4, wherein the core is formed integrally with thedeployable arms.
 8. A device as defined in claim 4, wherein theoverlapping segments of the sealing component project in a proximaldirection and the deployable arms project in a distal direction.
 9. Adevice as defined in claim 4, wherein the retainer frame furthercomprises a second set of deployable arms.
 10. A device as defined inclaim 9, wherein the second set of deployable arms are formed integrallywith the core.
 11. A device as defined in claim 9, wherein the secondset of deployable arms project in a proximal direction.
 12. A device asdefined in claim 9, wherein the second set of deployable arms arelaterally biased.
 13. A device as defined in claim 9, wherein the two ormore overlapping segments of the sealing component are supported by thesecond set of deployable arms.
 14. A device as defined in claim 4,wherein the two or more overlapping segments of the sealing componentare supported by the first set of deployable arms to maintain the sealof the bronchial lumen against fluid flow in a first direction.
 15. Adevice as defined in claim 14 wherein the overlapping segments areaxially deflectable away from the deployable arms to allow fluid flow ina second direction.
 16. A device as defined in claim 4, furthercomprising one or more sleeves slideably positioned over the retainerframe.
 17. A device as defined in claim 16, wherein the one or moresleeves are adapted to slide over the first set of deployable arms toradially collapse the deployable arms.
 18. A device as defined in claim16, wherein the one or more sleeves is adapted to be coupled to anactuation element for pushing or pulling the sleeves.
 19. A device asdefined in claim 18, wherein the one or more sleeves comprises areceptacle for receiving the actuation element.
 20. A device as definedin claim 16, wherein receptacle is adapted to allow removal of theactuation element therefrom.
 21. A device as defined in claim 1, whereineach overlapping segment has a radial edge configured to overlap anadjacent overlapping segment, the radial edge being unconnected to theadjacent overlapping segment.
 22. A device as defined in claim 1,wherein each overlapping segment has a radial edge configured to overlapan adjacent overlapping segment, the radial edge being connected to theadjacent overlapping segment.
 23. A device as defined in claim 1,wherein each of the overlapping segments is connected to another of theoverlapping segments by a foldable section.
 24. A device as defined inclaim 23, wherein the foldable section is less stiff than theoverlapping segments.
 25. A flow control device, comprising: a retainerframe comprising a core, a first set of deployable arms projecting fromthe core, and a second set of deployable arms projecting from the core;and a sealing component comprising two or more overlapping segments thatare movable relative to one another such that the segments collectivelyform a seal that can expand and contract in size to fit within and sealbronchial lumens of various sizes.
 26. A flow control device as definedin claim 25, wherein said two or more overlapping segments are attachedto the core of the retainer frame.
 27. A flow control device as definedin claim 25, wherein the two or more overlapping segments of the sealingcomponent are supported by the first set of deployable arms to maintainthe seal of the bronchial lumen against fluid flow in a first direction.28. A flow control device as defined in claim 27, wherein the two ormore overlapping segments of the sealing component are axiallydeflectable away from the first set of deployable arms to allow fluidflow through the bronchial lumen in a second direction.
 29. A flowcontrol device as defined in claim 25, further comprising one or moresleeves slideably positioned over the retainer frame.
 30. A flow controldevice as defined in claim 29, wherein the one or more sleeves areadapted for coupling to an actuation element for pushing or pulling theone or more sleeves.
 31. A flow control device as defined in claim 29,wherein the one or more sleeves are adapted to slide over the first andsecond sets of deployable arms to radially collapse the first and secondsets of deployable arms.
 32. A flow control device as defined in claim25, wherein the overlapping segments collectively form a conical shapeand wherein the diameter of the conical shape is variable by moving onesegment with respect to another segment.
 33. A flow control device asdefined in claim 25, wherein one of the first and second sets ofdeployable arms is configured to engage a wall of the bronchial lumen toanchor the device therein.
 34. A flow control device as defined in claim25, wherein each overlapping segment has a radial edge configured tooverlap an adjacent overlapping segment, the radial edge beingunconnected to the adjacent overlapping segment.
 35. A flow controldevice as defined in claim 21, wherein each overlapping segment has aradial edge configured to overlap an adjacent overlapping segment, theradial edge being connected to the adjacent overlapping segment.
 36. Aflow control device as defined in claim 25, wherein each of theoverlapping segments is connected to another of the overlapping segmentsby a foldable section.
 37. A flow control device as defined in claim 36,wherein the foldable section is less stiff than the overlappingsegments.
 38. A method of regulating fluid flow to and from a region ofan individual's lung, comprising: placing a flow control device in abronchial passage in communication with the region, the flow controldevice having a first set of one or more deployable arms in a collapsedconfiguration; and radially expanding the first set of one or moredeployable arms into engagement with a wall of the bronchial passage toanchor the flow control device therein; wherein the flow control devicehas a plurality of overlapping segments that are movable relative to oneanother and collectively form a seal with a wall of the bronchial lumenthat can expand and contract in size.
 39. A method as defined in claim38, wherein the overlapping segments form a seal against fluid flowthrough the bronchial passage into the region and are movable to allowfluid flow through the bronchial passage out of the region.
 40. A methodas defined in claim 38, wherein the overlapping segments are supportedby the first set of deployable arms.
 41. A method as defined in claim38, further comprising radially expanding a second set of one or moredeployable arms into engagement with the wall of the bronchial passage.42. A method as defined in claim 41, wherein the overlapping segmentsare supported by the second set of deployable arms.
 43. A method asdefined in claim 38 further comprising radially collapsing the first setof one or more deployable arms prior to placing the flow control devicein the bronchial passage.
 44. A method as defined in claim 43, whereinradially collapsing the deployable arms comprises positioning a sleeveover at least a portion of the one or more deployable arms.
 45. A methodas defined in claim 44, wherein the sleeve is slidably coupled to theflow control device.
 46. A method as defined in claims 44, whereinpositioning the sleeve comprises moving an actuator element coupled tothe sleeve.
 47. A method as defined in claim 38, further comprisingremoving the flow control device from the bronchial passage afterradially expanding the first set of one or more deployable arms.
 48. Amethod as defined in claim 47, wherein removing the flow control devicecomprises radially collapsing the first set of one or more deployablearms.
 49. A method as defined in claim 48 wherein radially collapsingthe first set of one or more deployable arms comprises positioning asleeve over at least a portion of the one or more deployable arms.
 50. Amethod as defined in claim 38, wherein the overlapping segmentscollectively form a conical shape and wherein the diameter of theconical shape can vary as one segment moves with respect to anothersegment.
 51. A method as defined in claim 30, wherein the overlappingsegments are interconnected by foldable sections.
 52. A flow controldevice for placement in a body lumen comprising: a frame comprising aplurality of struts connected to a distal hub, at least a portion ofeach strut biased outwardly from the distal hub; and a membrane coupledto the struts thereby forming an umbrella shape, wherein the frame urgesthe membrane into engagement with a wall of the body lumen to form aseal therewith.
 53. A flow control device as claimed in claim 52,further comprising a retention element attached to the frame andconfigured to engage the wall of the body lumen to anchor the flowcontrol device therein.
 54. A flow control device as claimed in claim53, wherein the retention element comprises one or more retention strutsprotruding laterally from the frame.
 55. A flow control device asclaimed in claim 52, wherein the retention element comprises a coilextending from the frame.
 56. A flow control device as claimed in 52,wherein the struts are curved.
 57. A flow control device as claimed in52, wherein one or more pleats are formed into the membrane between thestruts.
 58. A flow control device as claimed in 52, wherein the strutshave distal ends coupled to the distal hub and proximal ends connectedto a proximal hub, the struts being curved outwardly therebetween.
 59. Aflow control device as claimed in 58, wherein the proximal hub isaxially movable relative to the distal hub to vary the degree ofcurvature in the struts.
 60. A flow control device as claimed in 59,wherein the distal hub is connected to an axial member, the axial memberbeing movable relative to the proximal hub.
 61. A flow control device asclaimed in 60, wherein axial member comprises a cable.
 62. A flowcontrol device as claimed in 60, wherein the axial member comprises arod.
 63. A flow control device as claimed in 62, wherein the proximalhub is threadably coupled to the rod.
 64. A flow control device asclaimed in 58, wherein the membrane extends over a distal portion of thestruts.
 65. A flow control device as claimed in 58, further comprising aretention element attached to the proximal hub, the retention elementbeing configured to engage the wall of the body lumen to anchor the flowcontrol device therein.
 66. A flow control device as claimed in 65,wherein the retention element comprises a plurality of struts extendingoutwardly from the proximal hub.
 67. A flow control device as claimed in58, wherein the proximal hub comprises a locking mechanism for lockingthe proximal hub in place relative to the distal hub.
 68. A flow controldevice as claimed in 52, wherein the struts are radially collapsible sothat the flow control device can be inserted in the body lumen.
 69. Aflow control device as claimed in claim 52, wherein the struts have astiffness sufficient to tension the membrane when deployed in the bodylumen.
 70. A flow control device as claimed in claim 52, wherein thestruts have a stiffness sufficient to deform the body lumen into apolygonal shape.
 71. A flow control device as claimed in claim 52,wherein the membrane is sufficiently flexible to seal with the wall ofthe body lumen when the membrane is not tensioned by the struts.
 72. Aflow control device as claimed in claim 71, wherein the membrane has adurometer in the range of 40 Shore A to 100 Shore A.
 73. A flow controldevice as claimed in claim 52, further comprising a delivery devicereleasably coupled to the frame and configured to maintain the struts ina radially collapsed configuration.